Cleared Traditional

SUSSMAN FOUR MIRROR HAND HELD GONIOPRISM

K862024 · Ocular Instruments, Inc. · Ophthalmic
Jul 1986
Decision
44d
Days
Class 1
Risk

About This 510(k) Submission

K862024 is an FDA 510(k) clearance for the SUSSMAN FOUR MIRROR HAND HELD GONIOPRISM, a Prism, Gonioscopic (Class I — General Controls, product code HKS), submitted by Ocular Instruments, Inc. (Bellevue, US). The FDA issued a Cleared decision on July 11, 1986, 44 days after receiving the submission on May 28, 1986. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1660.

Submission Details

510(k) Number K862024 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 1986
Decision Date July 11, 1986
Days to Decision 44 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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