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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856447003674 | K133542 | 000 |
| 10818582010778 | K133542 | 000 |
| 10818582010785 | K133542 | 000 |
| 10818582010853 | K133542 | 000 |
| 10818582010990 | K133542 | 000 |
| 10818582011003 | K133542 | 000 |
| 10818582011010 | K133542 | 000 |
| 10818582011027 | K133542 | 000 |
| 10818582011317 | K133542 | 000 |
| 10818582011324 | K133542 | 000 |
| 10818582011331 | K133542 | 000 |
| 10818582011720 | K133542 | 000 |
| 00818582012096 | K133542 | 000 |
| 00818582012102 | K133542 | 000 |
| 10818582012437 | K133542 | 000 |
| 10818582012550 | K133542 | 000 |
| 10818582012567 | K133542 | 000 |
| 00856447003629 | K133542 | 000 |
| 10818582010761 | K133542 | 000 |