The following data is part of a premarket notification filed by Bioderm, Inc. with the FDA for Bioderm Calcium Alginate Dressing.
| Device ID | K980451 |
| 510k Number | K980451 |
| Device Name: | BIODERM CALCIUM ALGINATE DRESSING |
| Classification | Bandage, Liquid |
| Applicant | BIODERM, INC. P.O. BOX 4882 Wheaton, IL 60189 |
| Contact | George Worthley |
| Correspondent | George Worthley BIODERM, INC. P.O. BOX 4882 Wheaton, IL 60189 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-05 |
| Decision Date | 1998-04-09 |