The following data is part of a premarket notification filed by Dermaphylyx, Inc. with the FDA for Dermaphylyx Hydrocolloid Wound Dressing, Healian Hydrocolloid Wound Dressing.
| Device ID | K990891 |
| 510k Number | K990891 |
| Device Name: | DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | DERMAPHYLYX, INC. 12106, WEST 75TH LN. Arvada, CO 80005 -5306 |
| Contact | Andrew M Reed |
| Correspondent | Andrew M Reed DERMAPHYLYX, INC. 12106, WEST 75TH LN. Arvada, CO 80005 -5306 |
| Product Code | MGP |
| 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 | 1999-03-17 |
| Decision Date | 1999-05-27 |
| Summary: | summary |