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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intrauterine Tamponade Balloon
510(k) Number K223098
Device Name Bakri Essential Postpartum Balloon
Applicant
Cook Incorporated
750 Daniels Way
P.O. Box 489
Bloomington,  IN  47402
Applicant Contact Ian Herman
Correspondent
Cook Incorporated
750 Daniels Way
P.O. Box 489
Bloomington,  IN  47402
Correspondent Contact Ian Herman
Regulation Number884.4530
Classification Product Code
OQY  
Date Received09/30/2022
Decision Date 10/28/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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