Cleared Traditional

LANDERS NOTCHED VITRECTOMY LENS RING

K912268 · Ocular Instruments, Inc. · Ophthalmic
Aug 1991
Decision
77d
Days
Class 1
Risk

About This 510(k) Submission

K912268 is an FDA 510(k) clearance for the LANDERS NOTCHED 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 August 7, 1991, 77 days after receiving the submission on May 22, 1991. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K912268 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 1991
Decision Date August 07, 1991
Days to Decision 77 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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