The following data is part of a premarket notification filed by Derma Sciences Canada, Inc. with the FDA for Algicell Ag.
| Device ID | K052536 |
| 510k Number | K052536 |
| Device Name: | ALGICELL AG |
| Classification | Dressing, Wound, Drug |
| Applicant | DERMA SCIENCES CANADA, INC. 104 SHORTING RD. Toronto, Ontario, CA M1s 3s4 |
| Contact | Dela Sharmini Atheray |
| Correspondent | Dela 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 | 2005-09-15 |
| Decision Date | 2006-09-13 |