The following data is part of a premarket notification filed by Dermaphylyx, Inc. with the FDA for Dermaphylyx Calcium Alginate Wound Dressing.
| Device ID | K991608 |
| 510k Number | K991608 |
| Device Name: | DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING |
| Classification | Bandage, Liquid |
| 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 | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-10 |
| Decision Date | 1999-07-20 |
| Summary: | summary |