Cleared Traditional

ALCON SERIES 20000 LEGACY MACKOOL SYSTEM

K955789 · Alcon Laboratories · Ophthalmic
Mar 1996
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K955789 is an FDA 510(k) clearance for the ALCON SERIES 20000 LEGACY MACKOOL SYSTEM, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Alcon Laboratories (Fort Worth,, US). The FDA issued a Cleared decision on March 21, 1996, 90 days after receiving the submission on December 22, 1995. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K955789 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 1995
Decision Date March 21, 1996
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQC — Unit, Phacofragmentation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4670

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