The following data is part of a premarket notification filed by Derma Sciences, Inc. with the FDA for Medihoney Primary Dressings With Active Manuka Honey.
| Device ID | K072956 |
| 510k Number | K072956 |
| Device Name: | MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY |
| Classification | Dressing, Wound, Drug |
| Applicant | DERMA SCIENCES, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane DERMA SCIENCES, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| 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 | 2007-10-19 |
| Decision Date | 2007-11-07 |
| Summary: | summary |