Clearance Summary
SKIL-CARE SUPER-SOFT LIMB RESTRAINTS received FDA 510(k) clearance under submission number K792012, 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 1979-10-26.
- Submission: K792012
- Applicant / Sponsor: Skil-Care Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6760
- Decision date: 1979-10-26
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.