KITAZATO OPU NEEDLE

Needle, Assisted Reproduction

KITAZATO MEDICAL CO., LTD.

The following data is part of a premarket notification filed by Kitazato Medical Co., Ltd. with the FDA for Kitazato Opu Needle.

Pre-market Notification Details

Device IDK112462
510k NumberK112462
Device Name:KITAZATO OPU NEEDLE
ClassificationNeedle, Assisted Reproduction
Applicant KITAZATO MEDICAL CO., LTD. 611 WEST 5TH STREET Austin,  TX  78701
ContactRichard Vincins
CorrespondentRichard Vincins
KITAZATO MEDICAL CO., LTD. 611 WEST 5TH STREET Austin,  TX  78701
Product CodeMQE  
CFR Regulation Number884.6100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-08-26
Decision Date2012-11-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14580303269173 K112462 000
14580303269098 K112462 000
14580303269104 K112462 000
14580303269111 K112462 000
14580303269128 K112462 000
14580303269135 K112462 000
14580303269142 K112462 000
14580303269159 K112462 000
14580303269166 K112462 000
14580303269081 K112462 000

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