The following data is part of a premarket notification filed by American Biotech Labs with the FDA for Asap Antimicrobial Silver Wound Dressing Gel.
| Device ID | K092826 |
| 510k Number | K092826 |
| Device Name: | ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL |
| Classification | Dressing, Wound, Drug |
| Applicant | AMERICAN BIOTECH LABS 400 N. WASHINGTON ST. SUITE 100 Alexandria, VA 22314 |
| Contact | Miriam Provost |
| Correspondent | Miriam Provost AMERICAN BIOTECH LABS 400 N. WASHINGTON ST. SUITE 100 Alexandria, VA 22314 |
| 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 | 2009-09-14 |
| Decision Date | 2009-11-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10714196510157 | K092826 | 000 |
| 00714196392329 | K092826 | 000 |
| 00851213004350 | K092826 | 000 |
| 00851213004138 | K092826 | 000 |