The following data is part of a premarket notification filed by Amerx Health Care Corp. with the FDA for Amerigel Wound Dressing Plus 1/2 Oz. (15g Tube), Model A2025; 1 Oz. (30g Tube), Model A2026; 3 Oz (90g Tube),model A2027.
| Device ID | K092086 |
| 510k Number | K092086 |
| Device Name: | AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027 |
| Classification | Dressing, Wound, Drug |
| Applicant | AMERX HEALTH CARE CORP. 1300 S. HIGHLAND AVE. Clearwater, FL 33756 |
| Contact | Art W Simonetti, Lpn |
| Correspondent | Art W Simonetti, Lpn AMERX HEALTH CARE CORP. 1300 S. HIGHLAND AVE. Clearwater, FL 33756 |
| 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 | 2009-07-09 |
| Decision Date | 2009-07-30 |
| Summary: | summary |