Clearance Summary
DISPOS-A-CARE THERMOMETER SHEATH received FDA 510(k) clearance under submission number K770125, sponsored by Chesebrough-Pond'S U.S.A. Co.. 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 1977-03-14.
- Submission: K770125
- Applicant / Sponsor: Chesebrough-Pond'S U.S.A. Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2920
- Decision date: 1977-03-14
Classification & Regulation
This clearance is catalogued under FDA product code FLK and 21 CFR 880.2920, within the General Hospital review panel as a Class II device.