Cleared Traditional

MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM

K912904 · Mentor O & O, Inc. · Ophthalmic
Jun 1992
Decision
345d
Days
Class 2
Risk

About This 510(k) Submission

K912904 is an FDA 510(k) clearance for the MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM, 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 June 11, 1992, 345 days after receiving the submission on July 2, 1991. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K912904 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 1991
Decision Date June 11, 1992
Days to Decision 345 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HQC — Unit, Phacofragmentation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4670

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