The following data is part of a premarket notification filed by Puricore Inc. with the FDA for Puricore Wound Hydrogel Spray Dressing.
| Device ID | K141863 |
| 510k Number | K141863 |
| Device Name: | PURICORE WOUND HYDROGEL SPRAY DRESSING |
| 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 | 2014-07-10 |
| Decision Date | 2015-05-14 |
| Summary: | summary |