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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 K103357
Device Name LIFEBRIDGE
Applicant
Lifebridge Medizintechnik AG
1282 Round Hill Rd.
Bryn Mawr,  PA  19010
Applicant Contact KATHLEEN JOHNSON
Correspondent
Lifebridge Medizintechnik AG
1282 Round Hill Rd.
Bryn Mawr,  PA  19010
Correspondent Contact KATHLEEN JOHNSON
Regulation Number870.4360
Classification Product Code
KFM  
Date Received11/16/2010
Decision Date 12/27/2010
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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