The following data is part of a premarket notification filed by Abl Medical, Llc with the FDA for Asap Otc Wound Dressing Gel.
| Device ID | K140483 |
| 510k Number | K140483 |
| Device Name: | ASAP OTC WOUND DRESSING GEL |
| Classification | Dressing, Wound, Drug |
| Applicant | ABL MEDICAL, LLC 400 N. WASHINGTON ST., STE 100 Alexandria, VA 22314 |
| Contact | Calley Herzog |
| Correspondent | Calley Herzog ABL MEDICAL, LLC 400 N. WASHINGTON ST., STE 100 Alexandria, VA 22314 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2014-02-26 |
| Decision Date | 2014-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851213004329 | K140483 | 000 |
| 07290019556008 | K140483 | 000 |
| 00860010515402 | K140483 | 000 |
| 00860010515426 | K140483 | 000 |
| 00020424210946 | K140483 | 000 |
| 00851213004190 | K140483 | 000 |
| 00851213004213 | K140483 | 000 |
| 00851213004237 | K140483 | 000 |
| 00851213004251 | K140483 | 000 |
| 00851213004282 | K140483 | 000 |
| 00851213004299 | K140483 | 000 |
| 00020424321949 | K140483 | 000 |