Clearance Summary
PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET received FDA 510(k) clearance under submission number K950178, sponsored by Pharma-Plast Intl. A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1995-07-17.
- Submission: K950178
- Applicant / Sponsor: Pharma-Plast Intl. A/S
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.1520
- Decision date: 1995-07-17
Classification & Regulation
This clearance is catalogued under FDA product code LZE and 21 CFR 888.1520, within the Orthopedic review panel as a Class I device.