The following data is part of a premarket notification filed by Dr. Fresh, Inc. with the FDA for Dry Mouth Mouthwash.
| Device ID | K111250 |
| 510k Number | K111250 |
| Device Name: | DRY MOUTH MOUTHWASH |
| Classification | Saliva, Artificial |
| Applicant | DR. FRESH, INC. MEDICAL DEVICES 144 RESEARCH DRIVE Hampton, VA 23666 |
| Contact | Camille Thornton |
| Correspondent | Camille Thornton DR. FRESH, INC. MEDICAL DEVICES 144 RESEARCH DRIVE Hampton, VA 23666 |
| 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 | 2011-05-04 |
| Decision Date | 2012-04-27 |
| Summary: | summary |