Clearance Summary
BITE STICK, DYNA received FDA 510(k) clearance under submission number K760258, sponsored by Dyna-Med. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1976-07-26.
- Submission: K760258
- Applicant / Sponsor: Dyna-Med
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5070
- Decision date: 1976-07-26
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.