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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Pump, Cardiopulmonary Bypass
510(k) Number K080592
Device Name HLM TUBING SET WITH BIOLINE COATING
Applicant
MAQUET CARDIOPULMONARY AG
HECHINGER STRASSE 38
HIRRLINGEN,  DE 72145
Applicant Contact KATRIN SCHWENGLENKS
Correspondent
MAQUET CARDIOPULMONARY AG
HECHINGER STRASSE 38
HIRRLINGEN,  DE 72145
Correspondent Contact KATRIN SCHWENGLENKS
Regulation Number870.4390
Classification Product Code
DWE  
Subsequent Product Codes
DTL   DWF  
Date Received03/03/2008
Decision Date 09/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
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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