Cleared Traditional

MCDONALD FOLDING FORCEPS

K885230 · Alcon Laboratories · Ophthalmic
May 1989
Decision
148d
Days
Class 1
Risk

About This 510(k) Submission

K885230 is an FDA 510(k) clearance for the MCDONALD 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 May 17, 1989, 148 days after receiving the submission on December 20, 1988. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K885230 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 1988
Decision Date May 17, 1989
Days to Decision 148 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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