The following data is part of a premarket notification filed by Prugen Ip Holdings, Inc with the FDA for Hpr Emollient Foam.
| Device ID | K113772 |
| 510k Number | K113772 |
| Device Name: | HPR EMOLLIENT FOAM |
| Classification | Dressing, Wound, Drug |
| Applicant | PRUGEN IP HOLDINGS, INC 8714 E. VISTA BONITA DR. Scottsdale, AZ 85255 |
| Contact | Sean Lonergan |
| Correspondent | Sean Lonergan PRUGEN IP HOLDINGS, INC 8714 E. VISTA BONITA DR. 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 | No |
| Date Received | 2011-12-22 |
| Decision Date | 2012-02-09 |
| Summary: | summary |