Clearance Summary
CONDUCT ALOE GEL, #UP239-8FL. OZ/#UP245 G-1 GALLON received FDA 510(k) clearance under submission number K925466, sponsored by Uni-Patch, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1993-08-26.
- Submission: K925466
- Applicant / Sponsor: Uni-Patch, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1275
- Decision date: 1993-08-26
Classification & Regulation
This clearance is catalogued under FDA product code GYB and 21 CFR 882.1275, within the Neurology review panel as a Class II device.