Cleared Traditional

K955245 - MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM
(FDA 510(k) Clearance)

K955245 · Mentor O & O, Inc. · Ophthalmic

Feb 1996

Decision

89d

Days

Class 2

Risk

K955245 is an FDA 510(k) clearance for the MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM. This device is classified as a Unit, Phacofragmentation (Class II — Special Controls, product code HQC).

Submitted by Mentor O & O, Inc. (Norwell, US). The FDA issued a Cleared decision on February 12, 1996, 89 days after receiving the submission on November 15, 1995.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number	K955245 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 15, 1995
Decision Date	February 12, 1996
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF