The following data is part of a premarket notification filed by Prugen Ip Holdings, Inc with the FDA for Pruclair Nonsteroidal Cream.
| Device ID | K093156 |
| 510k Number | K093156 |
| Device Name: | PRUCLAIR NONSTEROIDAL CREAM |
| Classification | Dressing, Wound, Drug |
| Applicant | PRUGEN IP HOLDINGS, INC 8711 E PINNACLE PEAK ROAD SUITE C-201, PMB 225 Scottsdale, AZ 85255 |
| Contact | Robert L Knechtel |
| Correspondent | Robert L Knechtel PRUGEN IP HOLDINGS, INC 8711 E PINNACLE PEAK ROAD SUITE C-201, PMB 225 Scottsdale, AZ 85255 |
| 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 | 2009-10-06 |
| Decision Date | 2010-06-24 |
| Summary: | summary |