The following data is part of a premarket notification filed by Maxxim Medical with the FDA for Dermaplex Hydrogel Wound Dressing.
| Device ID | K962513 |
| 510k Number | K962513 |
| Device Name: | DERMAPLEX HYDROGEL WOUND DRESSING |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | MAXXIM MEDICAL 100 EAST 15TH ST. SUITE 320 Fort Worth, TX 76102 |
| Contact | Richard A Hamer |
| Correspondent | Richard A Hamer MAXXIM MEDICAL 100 EAST 15TH ST. SUITE 320 Fort Worth, TX 76102 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-27 |
| Decision Date | 1996-09-12 |
| Summary: | summary |