Clearance Summary
COLONGLIDE(R) LUBRICANT received FDA 510(k) clearance under submission number K131617, sponsored by Pediatric Pharmaceuticals, 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 2013-10-03.
- Submission: K131617
- Applicant / Sponsor: Pediatric Pharmaceuticals, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6375
- Decision date: 2013-10-03
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.