FDA 510(k) Application Details - K072172

Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

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510(K) Number K072172
Device Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant MAQUET CARDIOPULMONARY AG
HECHINGER STRASSE 38
HIRRLINGEN 72145 DE
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Contact KATRIN SCHWENGLENKS
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Regulation Number 870.4210

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Classification Product Code DWF
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Date Received 08/06/2007
Decision Date 08/31/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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