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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Assisted Reproduction
510(k) Number K160753
Device Name COOK Vacuum Pump
Applicant
William A. Cook Australia Pty. , Ltd.
95 Brandl St.
Eight Mile Plains,  AU 4113
Applicant Contact Gordana Pozvek
Correspondent
William A. Cook Australia Pty. , Ltd.
95 Brandl St.
Eight Mile Plains Qld 4113,  AU
Correspondent Contact Gordana Pozvek
Regulation Number884.6120
Classification Product Code
MQG  
Date Received03/18/2016
Decision Date 06/13/2017
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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