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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microtools, Assisted Reproduction (Pipettes)
510(k) Number K151018
Device Name Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette
Applicant
COOK INCORPORATED
750 DANIELS WAY
BLOOMINGTON,  IN  47404
Applicant Contact Naomi Funkhouser
Correspondent
COOK INCORPORATED
750 DANIELS WAY
BLOOMINGTON,  IN  47404
Correspondent Contact Naomi Funkhouser
Regulation Number884.6130
Classification Product Code
MQH  
Date Received04/16/2015
Decision Date 01/08/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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