Pivet And Soft-Pass Embryo Transfer Catheter Sets

Catheter, Assisted Reproduction

Cook Incorporated

The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Pivet And Soft-pass Embryo Transfer Catheter Sets.

Pre-market Notification Details

Device IDK173103
510k NumberK173103
Device Name:Pivet And Soft-Pass Embryo Transfer Catheter Sets
ClassificationCatheter, Assisted Reproduction
Applicant Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington,  IN  47402 -0489
ContactNaomi Funkhouser
CorrespondentNaomi Funkhouser
Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington,  IN  47402 -0489
Product CodeMQF  
CFR Regulation Number884.6110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-29
Decision Date2018-04-13
Summary:summary

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