OH WELL GOOD LUCK, Maybe-a-call-to-the FDA would help.... Maybe they will tell the exact date the 510k was submitted, might help figure out the right amount of days, then ask them how many hold days... Let us know please, The CDRH Transparency should take care of everything, just have to wait till Monday....
For many years, FDA's Center for Devices and Radiological Health (CDRH) has provided information to help industry comply with FDA regulations.
In support of the FDA Transparency Initiative, CDRH is providing additional information to help the public understand its processes and decisions. The new information includes:
information about regulatory decisions and the rationales for those decisions
descriptions of regulatory processes
data to support CDRH actions and public health activities
The list below contains information that CDRH is releasing for the first time. The additional pages on this Web site provide information about CDRH processes and decisions.
Recently Added Information
Topic Date
Evaluation of Automatic Class III Designation (De Novo) Summaries 10/14/15
Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes 08/10/15
Medical Device Recall Report, FY2003 to FY2012 (PDF - 818KB) 03/21/14
Overview of Medical Device Classification and Reclassification 12/17/13
Reclassification 12/17/13
515 Program Initiative 03/22/13
FDA Medical Device 2010 Quality System Data (PDF - 117KB) 05/23/11
Post-Approval Study Database Updated with new data fields describing the study Protocol
CDRH Inspections Database 09/30/10
Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers 07/08/10
Health Hazard Evaluations (HHEs) and Health Risk Assessments (HRAs) 07/01/10
Guidance for Industry, Third Parties and Food and Drug Administration Staff - Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program 03/19/12
Adverse Event Flowchart (PDF - 247KB) 05/19/10
Agenda and Materials From April 20, 2010 FDA Performance Report 04/20/10
Total Product Life Cycle (TPLC) 04/19/10
Overview of Medical Devices and Their Regulatory Pathways 04/19/10
Radiation-Emitting Products Industry Assistance: Walk-through 04/19/10
Key CDRH Databases and Resources
Premarket Approvals (PMA) Database Search
510(k) Premarket Notification Database Search
MAUDE Database Search
Recalls Database
Guidance Documents (Medical Devices and Radiation-Emitting Products)
CDRHNew - News and Updates
Search MedSun Reports
Other Transparency Resources
openFDA: Devices - Recall Enforcement Reports
FDA-TRACK: Agency-wide Program Performance
HHS Open Government
FDA Launches Medical Device and Radiation-Emitting Product Transparency Web site [ARCHIVED]
CDRH Transparency
Overview of CDRH Transparency
Total Product Life Cycle (TPLC)
Premarket Submissions
Postmarket Performance and Safety
Compliance & Enforcement
Science & Research
Educational Resources
CDRH Performance Data
CDRH Transparency Website Feedback Summary
Resources for You
Workshops & Conferences (Medical Devices)
Medical Devices Advisory Committees
Radiation-Emitting Products Advisory Committees
CDRH Management Directory by Organization
Medical Device Databases
Contact Us - Division of Industry and Consumer Education (DICE)
Page Last Updated: 10/14/2015
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