The following data is part of a premarket notification filed by Stiefel Laboratories, Inc. with the FDA for Impruv A.i. Cream Wound And Skin Emulsion.
| Device ID | K041342 |
| 510k Number | K041342 |
| Device Name: | IMPRUV A.I. CREAM WOUND AND SKIN EMULSION |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | STIEFEL LABORATORIES, INC. ROUTE 145 Oak Hill, NY 12460 |
| Contact | Mary Jane Carr |
| Correspondent | Mary Jane Carr STIEFEL LABORATORIES, INC. ROUTE 145 Oak Hill, NY 12460 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2004-05-20 |
| Decision Date | 2005-07-19 |
| Summary: | summary |