Cleared Traditional

CHIROFLEX FORCEPS

K903575 · Chiron Ophthalmics · Ophthalmic
Dec 1990
Decision
135d
Days
Class 1
Risk

About This 510(k) Submission

K903575 is an FDA 510(k) clearance for the CHIROFLEX FORCEPS, a Lens, Guide, Intraocular (Class I — General Controls, product code KYB), submitted by Chiron Ophthalmics (Irvine, US). The FDA issued a Cleared decision on December 21, 1990, 135 days after receiving the submission on August 8, 1990. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K903575 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 1990
Decision Date December 21, 1990
Days to Decision 135 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code KYB — Lens, Guide, Intraocular
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4300

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