The following data is part of a premarket notification filed by Bioderm, Inc. with the FDA for Bioderm Foam Wound Dressing.
| Device ID | K982778 |
| 510k Number | K982778 |
| Device Name: | BIODERM FOAM WOUND 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 (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-07 |
| Decision Date | 1998-10-21 |