The following data is part of a premarket notification filed by Derma Sciences, Inc. with the FDA for Dermagran Wound Management System.
| Device ID | K970660 |
| 510k Number | K970660 |
| Device Name: | DERMAGRAN WOUND MANAGEMENT SYSTEM |
| Classification | Bandage, Liquid |
| Applicant | DERMA SCIENCES, INC. 15825 SHADY GROVE RD. Rockville, MD 20850 |
| Contact | Kenneth A Palmer, Ph.d. |
| Correspondent | Kenneth A Palmer, Ph.d. DERMA SCIENCES, INC. 15825 SHADY GROVE RD. Rockville, MD 20850 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-21 |
| Decision Date | 1997-08-12 |
| Summary: | summary |