Clearance Summary
JOBST TRAVEL SOCKS received FDA 510(k) clearance under submission number K032325, sponsored by Bsn-Jobst, 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 2003-08-28.
- Submission: K032325
- Applicant / Sponsor: Bsn-Jobst, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5780
- Decision date: 2003-08-28
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.