MOJAVE CATARACT EXTRACTION SYSTEM

Unit, Phacofragmentation

ALLERGAN, INC.

The following data is part of a premarket notification filed by Allergan, Inc. with the FDA for Mojave Cataract Extraction System.

Pre-market Notification Details

Device IDK003638
510k NumberK003638
Device Name:MOJAVE CATARACT EXTRACTION SYSTEM
ClassificationUnit, Phacofragmentation
Applicant ALLERGAN, INC. 2525 DUPONT DR. P.O. BOX 19534 Irvine,  CA  92623 -9534
ContactMark O'donnell
CorrespondentMark O'donnell
ALLERGAN, INC. 2525 DUPONT DR. P.O. BOX 19534 Irvine,  CA  92623 -9534
Product CodeHQC  
CFR Regulation Number886.4670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-11-24
Decision Date2001-02-13

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