The following data is part of a premarket notification filed by Derma Sciences Canada, Inc. with the FDA for Honey Alginate Dressing.
| Device ID | K053095 |
| 510k Number | K053095 |
| Device Name: | HONEY ALGINATE DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | DERMA SCIENCES CANADA, INC. 104 SHORTING RD. Toronto, Ontario, CA M1s 3s4 |
| Contact | Sharmini Atheray |
| Correspondent | Sharmini Atheray DERMA SCIENCES CANADA, INC. 104 SHORTING RD. 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 | 2005-11-03 |
| Decision Date | 2007-07-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30381780486927 | K053095 | 000 |
| 30381780486910 | K053095 | 000 |
| 30381780486903 | K053095 | 000 |