The following data is part of a premarket notification filed by Abl Medical, Llc with the FDA for Agrx Wound Wash Antibacterial Silver Skin And Wound Cleanser (rx) And Agx Wound Wash Skin And Wound Cleanser (otc).
| Device ID | K151185 |
| 510k Number | K151185 |
| Device Name: | AGRX Wound Wash Antibacterial Silver Skin And Wound Cleanser (Rx) And AGX Wound Wash Skin And Wound Cleanser (OTC) |
| Classification | Dressing, Wound, Drug |
| Applicant | ABL Medical, LLC 705 E 50 S American Fork, UT 84003 |
| Contact | Robert Holladay |
| Correspondent | Calley Herzog BIOLOGICS CONSULTING GROUP, INC. 400 N. WASHINGTON STREET 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 | 2015-05-04 |
| Decision Date | 2016-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850044456413 | K151185 | 000 |
| 00020424270063 | K151185 | 000 |
| 00860010515433 | K151185 | 000 |
| 00860010515419 | K151185 | 000 |
| 00050428465851 | K151185 | 000 |
| 00810042271579 | K151185 | 000 |