Clearance Summary
FLUORO-SHIELD RADIATION REDUCTION GLOVES received FDA 510(k) clearance under submission number K920620, sponsored by Acufex Microsurgical, 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 1993-06-22.
- Submission: K920620
- Applicant / Sponsor: Acufex Microsurgical, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1993-06-22
Classification & Regulation
This clearance is catalogued under FDA product code LZC and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.