The following data is part of a premarket notification filed by Bioderm, Inc. with the FDA for Bioderm Medical Composite Wound Dressing.
| Device ID | K946292 |
| 510k Number | K946292 |
| Device Name: | BIODERM MEDICAL COMPOSITE WOUND DRESSING |
| Classification | Dressing, Wound And Burn, Occlusive |
| 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 | MGP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-27 |
| Decision Date | 1995-02-06 |