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FDA 510(k) Application Details - K100254
Device Classification Name
Catheter, Recording, Electrode, Reprocessed
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510(K) Number
K100254
Device Name
Catheter, Recording, Electrode, Reprocessed
Applicant
ASCENT HEALTHCARE SOLUTIONS
10232 SOUTH 51ST ST.
PHOENIX, AZ 85044 US
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Contact
AMANDA BABCOCK
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Regulation Number
870.1220
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Classification Product Code
NLH
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More FDA Info for this Product Code
Date Received
01/28/2010
Decision Date
05/28/2010
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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