Cleared Traditional

OMS/GONVERS RETINAL PERFORATOR

K844448 · Optical Micro Systems, Inc. · Ophthalmic
Aug 1985
Decision
278d
Days
Class 1
Risk

About This 510(k) Submission

K844448 is an FDA 510(k) clearance for the OMS/GONVERS RETINAL PERFORATOR, a Needle, Ophthalmic Suturing (Class I — General Controls, product code HNM), submitted by Optical Micro Systems, Inc. (Danvers, US). The FDA issued a Cleared decision on August 21, 1985, 278 days after receiving the submission on November 16, 1984. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K844448 FDA.gov
FDA Decision Cleared SESE
Date Received November 16, 1984
Decision Date August 21, 1985
Days to Decision 278 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HNM — Needle, Ophthalmic Suturing
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4350