PHACO CHOP NEEDLES

Unit, Phacofragmentation

BAUSCH & LOMB, INC.

The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Phaco Chop Needles.

Pre-market Notification Details

Device IDK041998
510k NumberK041998
Device Name:PHACO CHOP NEEDLES
ClassificationUnit, Phacofragmentation
Applicant BAUSCH & LOMB, INC. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis,  MO  63122 -6694
ContactDennis Pozzo
CorrespondentDennis Pozzo
BAUSCH & LOMB, INC. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis,  MO  63122 -6694
Product CodeHQC  
CFR Regulation Number886.4670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-07-26
Decision Date2004-08-16
Summary:summary

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