BD K-4000 MICROKERATOME SYSTEM

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 K-4000 Microkeratome System.

Pre-market Notification Details

Device IDK023092
510k NumberK023092
Device Name:BD K-4000 MICROKERATOME SYSTEM
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-09-18
Decision Date2002-10-18
Summary:summary

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