The following data is part of a premarket notification filed by Mowbray Co., Inc. with the FDA for Derma Prep.
| Device ID | K851612 |
| 510k Number | K851612 |
| Device Name: | DERMA PREP |
| Classification | Drape, Adhesive, Aerosol |
| Applicant | MOWBRAY CO., INC. 720 BROADWAY Waterloo, IA 50703 |
| Contact | Jerry S Pieters |
| Correspondent | Jerry S Pieters MOWBRAY CO., INC. 720 BROADWAY Waterloo, IA 50703 |
| Product Code | KGT |
| CFR Regulation Number | 878.4380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-18 |
| Decision Date | 1985-05-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DERMA PREP 75264404 not registered Dead/Abandoned |
Liage International Inc. 1997-03-26 |