FDA 510(k) Application Details - K993677

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

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510(K) Number K993677
Device Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant MEDTRONIC VASCULAR
620 WATSON STRET S.W.
GRAND RAPIDS, MI 49504 US
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Contact MICHAEL HINGSON
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Regulation Number 870.4210

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Classification Product Code DWF
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Date Received 11/01/1999
Decision Date 04/17/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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