The following data is part of a premarket notification filed by Syendgen, Inc. with the FDA for Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist.
| Device ID | K173237 |
| 510k Number | K173237 |
| Device Name: | Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist |
| Classification | Saliva, Artificial |
| Applicant | Syendgen, Inc. 1420 N. Claremont Blvd. Suite 105D Claremont, CA 91711 |
| Contact | Shenda Baker |
| Correspondent | Christopher Ryan Syendgen, Inc. 1420 N. Claremont Blvd. Suite 105D Claremont, CA 91711 |
| Product Code | LFD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-05 |
| Decision Date | 2018-03-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852181005059 | K173237 | 000 |
| 00852181005042 | K173237 | 000 |
| 00852181005141 | K173237 | 000 |
| 00852181005134 | K173237 | 000 |
| 00852181005097 | K173237 | 000 |