The following data is part of a premarket notification filed by Derma Sciences, Inc. with the FDA for Dermagran Wound Dressing.
Device ID | K924754 |
510k Number | K924754 |
Device Name: | DERMAGRAN WOUND DRESSING |
Classification | Gauze, External (with Drug/biologic/animal Source Material) |
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 | GER |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-23 |
Decision Date | 1993-05-27 |