Clearance Summary
MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD) received FDA 510(k) clearance under submission number K883416, sponsored by Scott All-Sports, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1988-10-12.
- Submission: K883416
- Applicant / Sponsor: Scott All-Sports, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5070
- Decision date: 1988-10-12
Classification & Regulation
This clearance is catalogued under FDA product code JXL and 21 CFR 882.5070, within the Neurology review panel as a Class II device.