Clearance Summary
ULTRA SEAL STERILE LUBRICATING JELLY received FDA 510(k) clearance under submission number K101522, sponsored by Ultra Seal Corporation. 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 2010-12-23.
- Submission: K101522
- Applicant / Sponsor: Ultra Seal Corporation
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6375
- Decision date: 2010-12-23
Classification & Regulation
This clearance is catalogued under FDA product code KMJ and 21 CFR 880.6375, within the General Hospital review panel as a Class I device.