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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)
CooperSurgical, Inc
95 Corporate Dr.
Trumbull,  CT  06611
Applicant Contact James Keller
Regulatory Compliance Associates, Inc.
10411 Corporate Drive, Suite 102
Pleasant Prairie,  WI  53158
Correspondent Contact Chris Henza
Regulation Number884.4530
Classification Product Code
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