Clearance Summary
TELESCOPE 4MM, 2.7MM DIAM. WIDE ANGLE 0', 30', 70', 4MM, DIAM, 30' WORK, L 14CM, AUTOCLAVABLE received FDA 510(k) clearance under submission number K953888, sponsored by Vista Medical Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1995-10-07.
- Submission: K953888
- Applicant / Sponsor: Vista Medical Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4760
- Decision date: 1995-10-07
Classification & Regulation
This clearance is catalogued under FDA product code EOB and 21 CFR 874.4760, within the Ear, Nose, Throat review panel as a Class II device.