Clearance Summary
BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOS received FDA 510(k) clearance under submission number K123820, sponsored by Bossong Hosiery Mills, Inc.. 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 2013-04-02.
- Submission: K123820
- Applicant / Sponsor: Bossong Hosiery Mills, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5780
- Decision date: 2013-04-02
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.