The following data is part of a premarket notification filed by Innovacyn, Inc. with the FDA for Puracyn Plus Skin And Wound.
| Device ID | K133542 |
| 510k Number | K133542 |
| Device Name: | PURACYN PLUS SKIN AND WOUND |
| Classification | Dressing, Wound, Drug |
| Applicant | INNOVACYN, INC. 3546 N. RIVERSIDE AVE. Rialto, CA 92377 |
| Contact | Fred L Ma |
| Correspondent | Fred L Ma INNOVACYN, INC. 3546 N. RIVERSIDE AVE. Rialto, CA 92377 |
| 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 | 2013-11-18 |
| Decision Date | 2014-04-28 |
| Summary: | summary |