The following data is part of a premarket notification filed by Derma Sciences, Inc. with the FDA for Medihoney Hydrogel Sheet Dressings With Active Leptospermum Honey.
| Device ID | K110546 |
| 510k Number | K110546 |
| Device Name: | MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY |
| Classification | Dressing, Wound, Drug |
| Applicant | DERMA SCIENCES, INC. 11440 W. BERNARDO COURT, SUITE 300 San Diego, CA 92127 |
| Contact | Ronald S Warren |
| Correspondent | Ronald S Warren DERMA SCIENCES, INC. 11440 W. BERNARDO COURT, SUITE 300 San Diego, CA 92127 |
| 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 | 2011-02-25 |
| Decision Date | 2011-07-27 |
| Summary: | summary |