The following data is part of a premarket notification filed by Derma Sciences, Inc. with the FDA for Derma Sciences Medihoney Dressings With Active Manuka Honey.
| Device ID | K080315 |
| 510k Number | K080315 |
| Device Name: | DERMA SCIENCES MEDIHONEY 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 | 2008-02-06 |
| Decision Date | 2008-04-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30381780486835 | K080315 | 000 |