The following data is part of a premarket notification filed by Derma Sciences Canada, Inc. with the FDA for Derma Sciences Calcium Alginate Dressing With Antimicrobial Silver (algicell Ag).
| Device ID | K080497 |
| 510k Number | K080497 |
| Device Name: | DERMA SCIENCES CALCIUM ALGINATE DRESSING WITH ANTIMICROBIAL SILVER (ALGICELL AG) |
| 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 | 2008-02-22 |
| Decision Date | 2008-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40612479183313 | K080497 | 000 |
| 30381780491693 | K080497 | 000 |
| 30381780491686 | K080497 | 000 |
| 30381780491679 | K080497 | 000 |
| 30381780491662 | K080497 | 000 |
| 30381780491655 | K080497 | 000 |
| 30381780491648 | K080497 | 000 |