Clearance Summary
TEMP-STIK MODEL #300 received FDA 510(k) clearance under submission number K791558, sponsored by Temp-Stik Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1979-09-12.
- Submission: K791558
- Applicant / Sponsor: Temp-Stik Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 1979-09-12
Classification & Regulation
This clearance is catalogued under FDA product code FLL and 21 CFR 880.2910, within the General Hospital review panel as a Class II device.