BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS

Lens, Contact (other Material) - Daily

BAUSCH & LOMB, INC.

The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Boston X02 (hexafocon B) Rigid Gas Permeable Contact Lens.

Pre-market Notification Details

Device IDK071266
510k NumberK071266
Device Name:BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS
ClassificationLens, Contact (other Material) - Daily
Applicant BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester,  NY  14609 -3547
ContactMichael A Santalucia
CorrespondentMichael A Santalucia
BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester,  NY  14609 -3547
Product CodeHQD  
CFR Regulation Number886.5916 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-05-07
Decision Date2007-08-15
Summary:summary

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