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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 K143415
Device Name Air Bubble Based Infuser (ABBI)
Applicant
CooperSurgical, Inc.
95 Corporate Dr.
Trumbull,  CT  06611
Applicant Contact James Keller
Correspondent
Regulatory Compliance Associates, Inc.
10411 Corporate Dr.
Suite 102
Pleasant Prarie,  WI  53158
Correspondent Contact Chris Henza
Regulation Number884.4530
Classification Product Code
LKF  
Date Received11/28/2014
Decision Date 02/26/2015
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
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