The following data is part of a premarket notification filed by American Biotech Labs with the FDA for Asap Wound Dressing Gel.
| Device ID | K082333 |
| 510k Number | K082333 |
| Device Name: | ASAP WOUND DRESSING GEL |
| Classification | Dressing, Wound, Drug |
| Applicant | AMERICAN BIOTECH LABS 1400 16TH STREET NW SUITE 101 Washington, DC 20036 |
| Contact | James S Turner |
| Correspondent | James S Turner AMERICAN BIOTECH LABS 1400 16TH STREET NW SUITE 101 Washington, DC 20036 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2008-08-14 |
| Decision Date | 2009-04-02 |
| Summary: | summary |