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FDA 510(k) Application Details - K020515
Device Classification Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
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510(K) Number
K020515
Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant
JOSTRA AG
478 MEDIA RD.
OXFORD, PA 19363 US
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Contact
KATHLEEN JOHNSON
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Regulation Number
870.4210
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Classification Product Code
DWF
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More FDA Info for this Product Code
Date Received
02/15/2002
Decision Date
04/24/2002
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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