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FDA 510(k) Application Details - K050217
Device Classification Name
Catheter,Intracardiac Mapping,High-Density Array
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510(K) Number
K050217
Device Name
Catheter,Intracardiac Mapping,High-Density Array
Applicant
BIOSENSE WEBSTER, INC.
3333 DIAMOND CANYON RD.
DIAMOND BAR, CA 91765 US
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Contact
WAYNE R HOHMAN
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Regulation Number
870.1220
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Classification Product Code
MTD
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More FDA Info for this Product Code
Date Received
01/31/2005
Decision Date
03/30/2005
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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