Cleared Traditional

LANDERS THREE STRUT VITRECTOMY LENS RING

K912151 · Ocular Instruments, Inc. · Ophthalmic
Jul 1991
Decision
71d
Days
Class 1
Risk

About This 510(k) Submission

K912151 is an FDA 510(k) clearance for the LANDERS THREE STRUT VITRECTOMY LENS RING, a Ring, Ophthalmic (flieringa) (Class I — General Controls, product code HNH), submitted by Ocular Instruments, Inc. (Bellevue, US). The FDA issued a Cleared decision on July 25, 1991, 71 days after receiving the submission on May 15, 1991. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K912151 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 1991
Decision Date July 25, 1991
Days to Decision 71 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HNH — Ring, Ophthalmic (flieringa)
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4350

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