The following data is part of a premarket notification filed by Puricore Inc. with the FDA for Vashe Wound Cleansing System.
| Device ID | K093155 |
| 510k Number | K093155 |
| Device Name: | VASHE WOUND CLEANSING SYSTEM |
| 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 | Yes |
| Date Received | 2009-10-06 |
| Decision Date | 2010-03-01 |
| Summary: | summary |