Cleared Traditional

PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR

K893199 · Allergan Medical Optics · Ophthalmic
Jun 1989
Decision
51d
Days
Class 1
Risk

About This 510(k) Submission

K893199 is an FDA 510(k) clearance for the PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR, a Forceps, Ophthalmic (Class I — General Controls, product code HNR), submitted by Allergan Medical Optics (Anasco, US). The FDA issued a Cleared decision on June 16, 1989, 51 days after receiving the submission on April 26, 1989. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K893199 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 1989
Decision Date June 16, 1989
Days to Decision 51 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HNR — Forceps, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4350