The following data is part of a premarket notification filed by Puricore Inc. with the FDA for Vashe Wound Solution (4.0 Oz), (8.5 Oz & (16.0 Oz).
| Device ID | K131848 |
| 510k Number | K131848 |
| Device Name: | VASHE WOUND SOLUTION (4.0 OZ), (8.5 OZ & (16.0 OZ) |
| Classification | Dressing, Wound, Drug |
| Applicant | PURICORE INC. 508 LAPP RD. Malvern, PA 19355 |
| Contact | Art Morse |
| Correspondent | Art Morse 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 | 2013-06-21 |
| Decision Date | 2014-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10851383003129 | K131848 | 000 |
| 10851383003143 | K131848 | 000 |
| 00851383003139 | K131848 | 000 |
| 10851383003167 | K131848 | 000 |
| 10851383003235 | K131848 | 000 |
| 10851383003228 | K131848 | 000 |
| 10851383003174 | K131848 | 000 |