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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
510(k) Number K131206
Device Name COOK CERVICAL RIPENING BALLOON
Applicant
Cook, Inc.
750 Daniels Way
Bloomington,  IN  47404
Applicant Contact CHIRS KILANDER
Correspondent
Cook, Inc.
750 Daniels Way
Bloomington,  IN  47404
Correspondent Contact CHIRS KILANDER
Regulation Number884.4260
Classification Product Code
PFJ  
Date Received04/29/2013
Decision Date 09/27/2013
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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