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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 K150573
Device Name ebb Complete Tamponade System
Applicant
Clinical Innovations, LLC
747 W 4170 S
Murray,  UT  84123
Applicant Contact Tom Haueter
Correspondent
Clinical Innovations, LLC
747 W 4170 S
Murray,  UT  84123
Correspondent Contact Tom Haueter
Regulation Number884.4530
Classification Product Code
OQY  
Date Received03/06/2015
Decision Date 03/25/2015
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
Recalls CDRH Recalls
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