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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name reservoir, blood, cardiopulmonary bypass
510(k) Number K070605
Device Name JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING
Applicant
MAQUET CARDIOPULMONARY AG
HECHINGER STRASSE 38
HIRRLINGEN,  DE 72145
Applicant Contact KATRIN SCHWENKGLENKS
Correspondent
MAQUET CARDIOPULMONARY AG
HECHINGER STRASSE 38
HIRRLINGEN,  DE 72145
Correspondent Contact KATRIN SCHWENKGLENKS
Regulation Number870.4400
Classification Product Code
DTN  
Date Received03/05/2007
Decision Date 01/04/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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