The following data is part of a premarket notification filed by Prugen, Inc. with the FDA for Prumyx Cream.
| Device ID | K082089 |
| 510k Number | K082089 |
| Device Name: | PRUMYX CREAM |
| Classification | Dressing, Wound, Drug |
| Applicant | PRUGEN, INC. 10 SOUTH LASALLE STREET SUITE 3300 Chicago, IL 60603 |
| Contact | Robert L Knechtel |
| Correspondent | Robert L Knechtel PRUGEN, INC. 10 SOUTH LASALLE STREET SUITE 3300 Chicago, IL 60603 |
| 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 | 2008-07-24 |
| Decision Date | 2009-01-13 |
| Summary: | summary |