The following data is part of a premarket notification filed by Derma Sciences, Inc. with the FDA for Dermagran Hydrophilic Ointment.
| Device ID | K954739 |
| 510k Number | K954739 |
| Device Name: | DERMAGRAN HYDROPHILIC OINTMENT |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | DERMA SCIENCES, INC. 121 WEST GRACE ST. Old Forge, PA 18518 |
| Contact | Howard Enfiejian |
| Correspondent | Howard Enfiejian DERMA SCIENCES, INC. 121 WEST GRACE ST. Old Forge, PA 18518 |
| 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 | 1995-10-16 |
| Decision Date | 1995-11-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40612479148374 | K954739 | 000 |
| 30381780491815 | K954739 | 000 |