The following data is part of a premarket notification filed by Puricore Inc. with the FDA for Vashe Wound Therapy System Model: 9000-0014.
| Device ID | K100918 |
| 510k Number | K100918 |
| Device Name: | VASHE WOUND THERAPY SYSTEM MODEL: 9000-0014 |
| Classification | Dressing, Wound, Drug |
| Applicant | PURICORE INC. 508 LAPP RD. Malvern, PA 19355 |
| Contact | Dennis Mahoney |
| Correspondent | Dennis Mahoney PURICORE INC. 508 LAPP RD. 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 | 2010-04-02 |
| Decision Date | 2010-08-09 |
| Summary: | summary |