Clearance Summary
JOBST READY-TO-WEAR ARM SLEEVES received FDA 510(k) clearance under submission number K991570, sponsored by Beiersdorf-Jobt, 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 1999-08-20.
- Submission: K991570
- Applicant / Sponsor: Beiersdorf-Jobt, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5780
- Decision date: 1999-08-20
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.