Clearance Summary
PDI PREPMASTER WET PACK MINOR PROCEDURE received FDA 510(k) clearance under submission number K840344, 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 1984-03-26.
- Submission: K840344
- Applicant / Sponsor: Nice-Pak Products, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6850
- Decision date: 1984-03-26
Classification & Regulation
This clearance is catalogued under FDA product code FRG and 21 CFR 880.6850, within the General Hospital review panel as a Class II device.