The following data is part of a premarket notification filed by Synedgen Inc. with the FDA for Synepure Wound Cleanser.
| Device ID | K143444 |
| 510k Number | K143444 |
| Device Name: | SynePure Wound Cleanser |
| Classification | Dressing, Wound, Drug |
| Applicant | Synedgen Inc. 1420 N. Claremont Blvd Apt.105D Claremont, CA 91711 |
| Contact | Shenda Baker |
| Correspondent | Shenda Baker Synedgen Inc. 1420 N. Claremont Blvd Apt.105D Claremont, CA 91711 |
| 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 | 2014-12-02 |
| Decision Date | 2015-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852181005301 | K143444 | 000 |
| 00852181005295 | K143444 | 000 |