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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
510(k) Number K111384
Device Name LIFEBRIDGE
Applicant
Lifebridge Medizintechnik AG
P.O. Box 2042
Fairfield,  IA  52556
Applicant Contact KATHLEEN JOHNSON
Correspondent
Lifebridge Medizintechnik AG
P.O. Box 2042
Fairfield,  IA  52556
Correspondent Contact KATHLEEN JOHNSON
Regulation Number870.4360
Classification Product Code
KFM  
Date Received05/17/2011
Decision Date 05/24/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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