meddevicedb.com FDA Device Reference

Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray

K180680 Traditional
Decision Date
2018-10-11
Sponsor / Applicant
Laclede, Inc.

Technical Specification

510(k) Submission ID K180680
Product Code LFD
Medical Specialty / Panel Unknown
Decision Date 2018-10-11
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray received FDA 510(k) clearance under submission number K180680, sponsored by Laclede, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2018-10-11.

Classification & Regulation

This clearance is catalogued under FDA product code LFD , within the Unknown review panel as a device.