Clearance Summary
CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 received FDA 510(k) clearance under submission number K010644, sponsored by Skil-Care 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 2001-05-18.
- Submission: K010644
- Applicant / Sponsor: Skil-Care Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6760
- Decision date: 2001-05-18
Classification & Regulation
This clearance is catalogued under FDA product code FMQ and 21 CFR 880.6760, within the General Hospital review panel as a Class I device.