Clearance Summary
JOBST READY-TO-WEAR GAUNTLET received FDA 510(k) clearance under submission number K013852, 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 2002-01-28.
- Submission: K013852
- Applicant / Sponsor: Bsn-Jobst, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5780
- Decision date: 2002-01-28
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.