The following data is part of a premarket notification filed by Synedgen, Inc. with the FDA for Synvaza Mouth Sore And Wound Rinse, Synvaza Ii Mouth Sore And Wound Rinse.
| Device ID | K193336 |
| 510k Number | K193336 |
| Device Name: | Synvaza Mouth Sore And Wound Rinse, Synvaza II Mouth Sore And Wound Rinse |
| Classification | Oral Wound Dressing |
| Applicant | Synedgen, Inc. 1420 North Claremont Blvd. Suite 105D Claremont, CA 91711 |
| Contact | Shenda Baker |
| Correspondent | Christopher Ryan Synedgen, Inc. 1420 North Claremont Blvd. Suite 105D Claremont, CA 91711 |
| Product Code | OLR |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-02 |
| Decision Date | 2020-05-27 |