Grapefruit USA Inc (GPFT)

[BennyJ]

Approval is closer - Read...(Reposting)


Below information is the final response received and SE date
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See approval link below:
http://www.accessdata.fda.gov/cdrh_docs/pdf9/K092564.pdf

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration
10903 New Hampshire Avenue
Document Control Room - W066-G609
Silver Spring, MD 20993-0002


SE DECISTION DATE : JUNE 17, 2010

Mr. Seth Kuzdzal
RA/QA Manager
Medtronic Navigation, Inc., Littleton
300 Foster Street
LITTLETON MA 01460
Re: K092564
Trade/Device Name: 0-arm®W Imaging System
Regulation Number: 21 CFR 892.1720
Regulation Name: Mobile x-ray system
Regulatory Class: II
Product Code: IZL and LHN

Dated: June 10, 2010
Received: June 11,2010

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Below information is the first submission received and SE date

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http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=31850

Device Classification Name system, x-ray, mobile
510(k) Number K092564
Device Name O-ARM IMAGING SYSTEM
Applicant MEDTRONIC NAVIGATION, INC. (LITTLETON)
300 foster street
littleton, MA 01460

Contact seth kuzdzal
Regulation Number 892.1720
Classification Product Code IZL

Subsequent Product Code LHN

Date Received 08/20/2009
Decision Date 06/17/2010

Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Statement/Summary/Purged Status Summary only
Type Abbreviated
Reviewed by Third Party No
Expedited Review No