FDA 510(k) Application Details - K874853

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

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510(K) Number K874853
Device Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant POLYSTAN C/O VITALCOR, INC.
100 E. CHESTNUT AVE.
WESTMONT, IL US
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Contact BILL HUCK
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Regulation Number 870.4210

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Classification Product Code DWF
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Date Received 11/25/1987
Decision Date 02/05/1988
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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