The following data is part of a premarket notification filed by Amerx Health Care Corp. with the FDA for Amerigel Ointment Saturated Wound Dressing.
| Device ID | K971918 |
| 510k Number | K971918 |
| Device Name: | AMERIGEL OINTMENT SATURATED WOUND DRESSING |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | AMERX HEALTH CARE CORP. 1150 CLEVELAND ST. SUITE 410 Clearwater, FL 34615 |
| Contact | Ron Maddix |
| Correspondent | Ron Maddix AMERX HEALTH CARE CORP. 1150 CLEVELAND ST. SUITE 410 Clearwater, FL 34615 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-23 |
| Decision Date | 1997-08-12 |