Cleared Traditional

MENTOR ANTERIOR SEGMENT VITRECTOR

K890595 · Mentor O & O, Inc. · Ophthalmic

Apr 1989

Decision

70d

Days

Class 2

Risk

About This 510(k) Submission

K890595 is an FDA 510(k) clearance for the MENTOR ANTERIOR SEGMENT VITRECTOR, a Instrument, Vitreous Aspiration And Cutting, Battery-powered (Class II — Special Controls, product code HKP), submitted by Mentor O & O, Inc. (Norwell, US). The FDA issued a Cleared decision on April 17, 1989, 70 days after receiving the submission on February 6, 1989. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number	K890595 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 06, 1989
Decision Date	April 17, 1989
Days to Decision	70 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—

Device Classification

Product Code	HKP — Instrument, Vitreous Aspiration And Cutting, Battery-powered
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 886.4150