Clearance Summary
PDI STERILE LUBRICATING JELLY received FDA 510(k) clearance under submission number K974768, sponsored by Nice-Pak Products, 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 1998-01-16.
- Submission: K974768
- Applicant / Sponsor: Nice-Pak Products, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6375
- Decision date: 1998-01-16
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.