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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 STREET
Eight Mile Plains,  AU 4113
Applicant Contact Gordana Pozvek
Correspondent
WILLIAM A. COOK AUSTRALIA PTY LTD
95 BRANDL STREET
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
Recalls CDRH Recalls
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