Clearance Summary
OPTI-DRAIN MULTI-USE DRAINAGE CATHETER received FDA 510(k) clearance under submission number K955505, sponsored by Navarre Biomedical , 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 1996-02-07.
- Submission: K955505
- Applicant / Sponsor: Navarre Biomedical , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4200
- Decision date: 1996-02-07
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.