The following data is part of a premarket notification filed by Synedgen, Inc with the FDA for Catasyn Advanced Technology Wound Hydrogel.
| Device ID | K172338 |
| 510k Number | K172338 |
| Device Name: | Catasyn Advanced Technology Wound Hydrogel |
| Classification | Dressing, Wound, Drug |
| Applicant | Synedgen, Inc 1420 N. Claremont Blvd., Suite 105D Claremont, CA 91711 |
| Contact | Shenda Baker |
| Correspondent | Shenda Baker Synedgen, Inc 1420 N. Claremont Blvd., Suite 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 | 2017-08-02 |
| Decision Date | 2018-02-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852181005332 | K172338 | 000 |