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FDA 510(k) Application Details - K991541
Device Classification Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
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510(K) Number
K991541
Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant
A-MED SYSTEMS, INC.
2491 BOATMAN AVE.
WEST SACRAMENTO, CA 95691 US
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Contact
ROBERTA THOMPSON
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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
05/03/1999
Decision Date
12/28/1999
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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