meddevicedb.com FDA Device Reference

DRY MOUTH MOUTHWASH

K111250 Traditional
Decision Date
2012-04-27
Sponsor / Applicant
Dr. Fresh, Inc.

Technical Specification

510(k) Submission ID K111250
Product Code LFD
Medical Specialty / Panel Unknown
Decision Date 2012-04-27
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

DRY MOUTH MOUTHWASH received FDA 510(k) clearance under submission number K111250, sponsored by Dr. Fresh, 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 2012-04-27.

Classification & Regulation

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