Clearance Summary
1-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-811, SS-508, SS-613 received FDA 510(k) clearance under submission number K092892, sponsored by I-Ming Sanitary Materials Co., Ltd.. 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 2010-08-03.
- Submission: K092892
- Applicant / Sponsor: I-Ming Sanitary Materials Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5780
- Decision date: 2010-08-03
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.