Clearance Summary
MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098 received FDA 510(k) clearance under submission number K062653, sponsored by Parnell Pharmaceuticals, 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 2006-10-27.
- Submission: K062653
- Applicant / Sponsor: Parnell Pharmaceuticals, Inc.
- Clearance pathway: Traditional
- Review panel: Unknown
- Device class:
- Decision date: 2006-10-27
Classification & Regulation
This clearance is catalogued under FDA product code LFD , within the Unknown review panel as a device.