The following data is part of a premarket notification filed by Dermaphylyx, Inc. with the FDA for Dermaphylyx Skin Protectors, Protect It Skin Protectors.
| Device ID | K992302 |
| 510k Number | K992302 |
| Device Name: | DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS |
| 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 (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-08 |
| Decision Date | 1999-09-14 |
| Summary: | summary |