Clearance Summary
LUBRICATING JELLY received FDA 510(k) clearance under submission number K871169, sponsored by H & P Industries, 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 1987-04-01.
- Submission: K871169
- Applicant / Sponsor: H & P Industries, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6375
- Decision date: 1987-04-01
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.