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FDA 510(k) Application Details - K130602
Device Classification Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
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510(K) Number
K130602
Device Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Applicant
BIOSENSE WEBSTER, INC.
3333 DIAMOND CANYON RD
DIAMOND BAR, CA 91765 US
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Contact
JOHN JIMENEZ
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Regulation Number
870.1220
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Classification Product Code
DRF
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More FDA Info for this Product Code
Date Received
03/07/2013
Decision Date
08/14/2013
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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