Clearance Summary
ELVAREX received FDA 510(k) clearance under submission number K963573, sponsored by Jobst A Beiersdorf Co.. 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 1996-10-16.
- Submission: K963573
- Applicant / Sponsor: Jobst A Beiersdorf Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5780
- Decision date: 1996-10-16
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.