The following data is part of a premarket notification filed by Derma Sciences, Inc. with the FDA for Dermagran Wound Cleanser With Zinc.
| Device ID | K945802 |
| 510k Number | K945802 |
| Device Name: | DERMAGRAN WOUND CLEANSER WITH ZINC |
| Classification | Bandage, Liquid |
| Applicant | DERMA SCIENCES, INC. 121 WEST GRACE ST. Old Forge, PA 18518 |
| Contact | Mary G Clark |
| Correspondent | Mary G Clark DERMA SCIENCES, INC. 121 WEST GRACE ST. Old Forge, PA 18518 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-28 |
| Decision Date | 1995-02-27 |