The following data is part of a premarket notification filed by Pierre Fabre Medical Devices with the FDA for Dexeryl Cream.
| Device ID | K113807 |
| 510k Number | K113807 |
| Device Name: | DEXERYL CREAM |
| Classification | Dressing, Wound, Drug |
| Applicant | PIERRE FABRE MEDICAL DEVICES 1129 TWENTIETH ST., NW SUITE 600 Washington, DC 20036 |
| Contact | Diane Mandell Horwitz |
| Correspondent | Diane Mandell Horwitz PIERRE FABRE MEDICAL DEVICES 1129 TWENTIETH ST., NW SUITE 600 Washington, DC 20036 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-23 |
| Decision Date | 2012-03-07 |
| Summary: | summary |