Arch Therapeutics Inc (ARTH)

[BooDog]

Edited: Product Classification:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=5643

Device dressing,wound,hydrogel w/out drug and/or biologic
Regulation Description Hydrogel wound dressing and burn dressing.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product Code NAE
Premarket Review Office of Device Evaluation 6(ODE)
Division of Surgical Devices (DSD)
Plastic and Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2)
Submission Type 510(K) Exempt
Regulation Number 878.40227
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report8
GMP Exempt? No
Note: FDA has exempted almost all class I devices (with the exception of reserved devices9) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-89210. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-89211, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website12 for additional information.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible

I mentioned a while back that while getting it would be great but they may not need it because of all the downgrading the fda has been doing. So if I'm right, we should move forward quickly. I'd post it but had to head out from the computer.

WE HAVE THE FDA STAMP!