Clearance Summary
MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET received FDA 510(k) clearance under submission number K972135, sponsored by P/L Biomedical. 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 1997-08-26.
- Submission: K972135
- Applicant / Sponsor: P/L Biomedical
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1997-08-26
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.