Cleared Traditional

ALCON FOLDING FORCEPS

K895434 · Alcon Laboratories · Ophthalmic
Dec 1989
Decision
87d
Days
Class 1
Risk

About This 510(k) Submission

K895434 is an FDA 510(k) clearance for the ALCON FOLDING FORCEPS, a Forceps, Ophthalmic (Class I — General Controls, product code HNR), submitted by Alcon Laboratories (Fort Worth, US). The FDA issued a Cleared decision on December 4, 1989, 87 days after receiving the submission on September 8, 1989. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K895434 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 1989
Decision Date December 04, 1989
Days to Decision 87 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

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