Clearance Summary
PHARMA-PLAST PURELINE(TM) BASIC(TM) AND PURELINE(TM) CONTACT(TM) SUBCUTANEOUS INFUSION SETS received FDA 510(k) clearance under submission number K945617, sponsored by Pharma-Plast Intl. A/S. 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 1995-02-13.
- Submission: K945617
- Applicant / Sponsor: Pharma-Plast Intl. A/S
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1995-02-13
Classification & Regulation
This clearance is catalogued under FDA product code FPA and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.