The following data is part of a premarket notification filed by Derma Sciences, Inc. with the FDA for Dermagran Hydrophilic Ointment.
| Device ID | K944491 |
| 510k Number | K944491 |
| Device Name: | DERMAGRAN HYDROPHILIC OINTMENT |
| 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 For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-13 |
| Decision Date | 1994-11-22 |