The following data is part of a premarket notification filed by Derma Sciences, Inc. with the FDA for Medihoney Wound Gel.
| Device ID | K150985 |
| 510k Number | K150985 |
| Device Name: | Medihoney Wound Gel |
| Classification | Dressing, Wound, Drug |
| Applicant | DERMA SCIENCES, INC. 104 SHORTING ROAD Toronto, Ontario, CA M1s 3s4 |
| Contact | Sharmini Atheray |
| Correspondent | Sharmini Atheray DERMA SCIENCES, INC. 104 SHORTING ROAD Toronto, Ontario, CA M1s 3s4 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-14 |
| Decision Date | 2015-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00809958036006 | K150985 | 000 |
| 30381780486897 | K150985 | 000 |
| 00050428539828 | K150985 | 000 |
| 00050428452547 | K150985 | 000 |