BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME

Keratome, Battery-powered

BECTON DICKINSON & CO.

The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Bd-3000 Microkeratome System, Model K-3000 Microkeratome.

Pre-market Notification Details

Device IDK022637
510k NumberK022637
Device Name:BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME
ClassificationKeratome, Battery-powered
Applicant BECTON DICKINSON & CO. 1 BECTON DR. Franklin Lakes,  NJ  07417 -1885
ContactEileen T Schweighardt
CorrespondentEileen T Schweighardt
BECTON DICKINSON & CO. 1 BECTON DR. Franklin Lakes,  NJ  07417 -1885
Product CodeHMY  
CFR Regulation Number886.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-08-08
Decision Date2002-10-16
Summary:summary

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