Cleared Traditional

MCINTYRE SURGICAL GONIOLENS

K890977 · Ocular Instruments, Inc. · Ophthalmic
May 1989
Decision
85d
Days
Class 1
Risk

About This 510(k) Submission

K890977 is an FDA 510(k) clearance for the MCINTYRE SURGICAL GONIOLENS, a Prism, Gonioscopic (Class I — General Controls, product code HKS), submitted by Ocular Instruments, Inc. (Bellevue, US). The FDA issued a Cleared decision on May 23, 1989, 85 days after receiving the submission on February 27, 1989. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1660.

Submission Details

510(k) Number K890977 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 1989
Decision Date May 23, 1989
Days to Decision 85 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HKS — Prism, Gonioscopic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1660

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