HANSATOME MICROKERATOME

Keratome, Ac-powered

BAUSCH & LOMB, INC.

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

Pre-market Notification Details

Device IDK010260
510k NumberK010260
Device Name:HANSATOME MICROKERATOME
ClassificationKeratome, Ac-powered
Applicant BAUSCH & LOMB, INC. 9342 JERONIMO RD. Irvine,  CA  92618
ContactPaul S Kramsky
CorrespondentPaul S Kramsky
BAUSCH & LOMB, INC. 9342 JERONIMO RD. Irvine,  CA  92618
Product CodeHNO  
CFR Regulation Number886.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-01-29
Decision Date2001-04-27

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