The following data is part of a premarket notification filed by Laclede, Inc. with the FDA for Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray.
| Device ID | K180680 |
| 510k Number | K180680 |
| Device Name: | Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray |
| Classification | Saliva, Artificial |
| Applicant | Laclede, Inc. 2103 E. University Dr. Rancho Dominguez, CA 90220 |
| Contact | Michael Pellico |
| Correspondent | Rajvinder Atwal Laclede, Inc. 2103 E. University Dr. Rancho Dominguez, CA 90220 |
| 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 | 2018-03-15 |
| Decision Date | 2018-10-11 |
| Summary: | summary |