The following data is part of a premarket notification filed by Dermaphylyx, Inc. with the FDA for Dermaphylyx Calcium Alginate Wound Dressing.
| Device ID | K991061 |
| 510k Number | K991061 |
| Device Name: | DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | DERMAPHYLYX, INC. 78-E,, OLYMPIA AVE. Woburn, MA 01801 -3933 |
| Contact | Andrew M Reed |
| Correspondent | Andrew M Reed DERMAPHYLYX, INC. 78-E,, OLYMPIA AVE. Woburn, MA 01801 -3933 |
| 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 | 1999-03-30 |
| Decision Date | 1999-06-28 |
| Summary: | summary |