The following data is part of a premarket notification filed by Adri with the FDA for Foam Calcium Alginate Topical Wound Dressing With Collagen.
| Device ID | K000054 |
| 510k Number | K000054 |
| Device Name: | FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN |
| Classification | Dressing, Wound, Collagen |
| Applicant | ADRI P.O. BOX 134 Park Forest, IL 60466 |
| Contact | George H Scherr |
| Correspondent | George H Scherr ADRI P.O. BOX 134 Park Forest, IL 60466 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-07 |
| Decision Date | 2000-03-13 |