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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Manipulator/Injector, Uterine
510(k) Number K141523
Device Name ALLY UPS
Applicant
CooperSurgical, Inc.
80 Shelton Technology Center
Shelton,  CT  06484
Applicant Contact TIM M LOHNES
Correspondent
CooperSurgical, Inc.
80 Shelton Technology Center
Shelton,  CT  06484
Correspondent Contact TIM M LOHNES
Regulation Number884.4530
Classification Product Code
LKF  
Date Received06/09/2014
Decision Date 11/25/2014
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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