The following data is part of a premarket notification filed by Puricore, Inc. with the FDA for Vashe Skin And Wound Hydrogel.
| Device ID | K123071 |
| 510k Number | K123071 |
| Device Name: | VASHE SKIN AND WOUND HYDROGEL |
| Classification | Dressing, Wound, Drug |
| Applicant | PURICORE, INC. 508 LAPP ROAD Malvern, PA 19355 |
| Contact | Art Morse |
| Correspondent | Art Morse PURICORE, INC. 508 LAPP ROAD Malvern, PA 19355 |
| 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 | 2012-10-01 |
| Decision Date | 2013-01-24 |
| Summary: | summary |