Clearance Summary
PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16, received FDA 510(k) clearance under submission number K844876, sponsored by Pennine Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1985-06-05.
- Submission: K844876
- Applicant / Sponsor: Pennine Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4200
- Decision date: 1985-06-05
Classification & Regulation
This clearance is catalogued under FDA product code GBX and 21 CFR 878.4200, within the General, Plastic Surgery review panel as a Class I device.