Cleared Traditional

LANDERS VITRECTOMY LENS RING SYSTEMS

K850991 · Ocular Instruments, Inc. · Ophthalmic
Mar 1985
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K850991 is an FDA 510(k) clearance for the LANDERS VITRECTOMY LENS RING SYSTEMS, 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 March 29, 1985, 18 days after receiving the submission on March 11, 1985. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K850991 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 1985
Decision Date March 29, 1985
Days to Decision 18 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

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

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