Clearance Summary
PHARMA-PLAST SMOOTH BORE CONNECTORS received FDA 510(k) clearance under submission number K843476, sponsored by Zimmar Consulting , Ltd.. 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 1984-09-24.
- Submission: K843476
- Applicant / Sponsor: Zimmar Consulting , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6740
- Decision date: 1984-09-24
Classification & Regulation
This clearance is catalogued under FDA product code GAZ and 21 CFR 880.6740, within the General Hospital review panel as a Class II device.