PHAKOSYSTEMS MODEL CES 4100

Unit, Phacofragmentation

PHAKOSYSTEMS, INC.

The following data is part of a premarket notification filed by Phakosystems, Inc. with the FDA for Phakosystems Model Ces 4100.

Pre-market Notification Details

Device IDK851674
510k NumberK851674
Device Name:PHAKOSYSTEMS MODEL CES 4100
ClassificationUnit, Phacofragmentation
Applicant PHAKOSYSTEMS, INC. 522 CHAMPAGNE DR. DOWNSVIEW, ONTARIO Canada,  CA M3j 2t9
ContactKeith L Carter
CorrespondentKeith L Carter
PHAKOSYSTEMS, INC. 522 CHAMPAGNE DR. DOWNSVIEW, ONTARIO Canada,  CA M3j 2t9
Product CodeHQC  
CFR Regulation Number886.4670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-04-23
Decision Date1985-08-05

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