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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 K170622
Device Name Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component
Applicant
Cook Incorporated
750 Daniels Way, P.O. Box 489
Bloomington,  IN  47402
Applicant Contact Naomi Funkhouser
Correspondent
Cook Incorporated
750 Daniels Way, P.O. Box 489
Bloomington,  IN  47402
Correspondent Contact Naomi Funkhouser
Regulation Number884.4530
Classification Product Code
OQY  
Date Received03/01/2017
Decision Date 03/31/2017
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
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