Clearance Summary
NIPRO SAFELET CATH received FDA 510(k) clearance under submission number K894371, sponsored by Pharma-Plast USA, 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 1989-10-25.
- Submission: K894371
- Applicant / Sponsor: Pharma-Plast USA, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 1989-10-25
Classification & Regulation
This clearance is catalogued under FDA product code FOZ and 21 CFR 880.5200, within the General Hospital review panel as a Class II device.