The following data is part of a premarket notification filed by Derma Sciences, Inc. with the FDA for Medihoney Wound Dressings.
| Device ID | K133279 |
| 510k Number | K133279 |
| Device Name: | MEDIHONEY WOUND DRESSINGS |
| 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 | Yes |
| Date Received | 2013-10-24 |
| Decision Date | 2015-06-25 |
| Summary: | summary |