Clearance Summary
PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S) received FDA 510(k) clearance under submission number K972749, sponsored by C.M. Chance , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1998-03-13.
- Submission: K972749
- Applicant / Sponsor: C.M. Chance , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4100
- Decision date: 1998-03-13
Classification & Regulation
This clearance is catalogued under FDA product code HQR and 21 CFR 886.4100, within the Ophthalmic review panel as a Class II device.