Cleared Traditional

DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY

K864292 · Eye-Ko, Inc. · Ophthalmic
Dec 1986
Decision
59d
Days
Class 1
Risk

About This 510(k) Submission

K864292 is an FDA 510(k) clearance for the DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY, a Hook, Ophthalmic (Class I — General Controls, product code HNQ), submitted by Eye-Ko, Inc. (West Chester, US). The FDA issued a Cleared decision on December 29, 1986, 59 days after receiving the submission on October 31, 1986. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K864292 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 1986
Decision Date December 29, 1986
Days to Decision 59 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HNQ — Hook, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4350