Clearance Summary
COMFORT SHEER FIRM AND SHEER SUPPORT PANTYHOSE received FDA 510(k) clearance under submission number K894071, sponsored by Sara Lee 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 1989-10-18.
- Submission: K894071
- Applicant / Sponsor: Sara Lee Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5780
- Decision date: 1989-10-18
Classification & Regulation
This clearance is catalogued under FDA product code DWL and 21 CFR 880.5780, within the General Hospital review panel as a Class II device.