The following data is part of a premarket notification filed by Adri with the FDA for Foam Calcium Aliginate Topical Wound Dressing.
| Device ID | K963656 |
| 510k Number | K963656 |
| Device Name: | FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING |
| Classification | Bandage, Liquid |
| 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 | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-12 |
| Decision Date | 1996-11-12 |