Cryotec

Labware, Assisted Reproduction

REPROLIFE INC.

The following data is part of a premarket notification filed by Reprolife Inc. with the FDA for Cryotec.

Pre-market Notification Details

Device IDK162051
510k NumberK162051
Device Name:Cryotec
ClassificationLabware, Assisted Reproduction
Applicant REPROLIFE INC. 2-5-5-8F, SHINJUKU Shinjuku-ku,  JP 160-0022
ContactKoichi Takeda
CorrespondentDiane Sudduth
EMERGO GROUP 816 CONGRESS AVENUE, SUITE 1400 Austin,  TX  78701
Product CodeMQK  
CFR Regulation Number884.6160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-07-25
Decision Date2016-12-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04589700010206 K162051 000
04589700010091 K162051 000
04589700010084 K162051 000
04589700010077 K162051 000
04589700010060 K162051 000
04589700010053 K162051 000
04589700010046 K162051 000
04589700010039 K162051 000
04589700010022 K162051 000
04589700010107 K162051 000
04589700010114 K162051 000
04589700010190 K162051 000
04589700010183 K162051 000
04589700010176 K162051 000
04589700010169 K162051 000
04589700010152 K162051 000
04589700010145 K162051 000
04589700010138 K162051 000
04589700010121 K162051 000
04589700010015 K162051 000

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