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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, assisted reproduction
510(k) Number K191015
Device Name Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip)
Applicant
Cook Incorporated
750 Daniels Way P.O. Box 489
bloomington,  IN  47402
Applicant Contact ian herrman
Correspondent
Cook Incorporated
750 Daniels Way P.O. Box 489
bloomington,  IN  47402
Correspondent Contact ian herrman
Regulation Number884.6110
Classification Product Code
MQF  
Date Received04/17/2019
Decision Date 05/17/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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