Clearance Summary
STERI-LUB LUBRICATION GEL received FDA 510(k) clearance under submission number K083189, sponsored by Avail Medical Products, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2008-11-21.
- Submission: K083189
- Applicant / Sponsor: Avail Medical Products, Inc.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6375
- Decision date: 2008-11-21
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.