The following data is part of a premarket notification filed by Bioderm Sciences, Inc. with the FDA for Bioderm Sciences Wound Cream.
| Device ID | K042352 |
| 510k Number | K042352 |
| Device Name: | BIODERM SCIENCES WOUND CREAM |
| Classification | Dressing, Wound, Drug |
| Applicant | BIODERM SCIENCES, INC. 101 ORCHARD RIDGE DR. SUITE 1N Gaithersburg, MD 20878 |
| Contact | Edward R Gubish |
| Correspondent | Edward R Gubish BIODERM SCIENCES, INC. 101 ORCHARD RIDGE DR. SUITE 1N Gaithersburg, MD 20878 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2004-08-30 |
| Decision Date | 2005-10-17 |
| Summary: | summary |