FDA 510(k) Application Details - K965066

Device Classification Name Catheter, Electrode Recording, Or Probe, Electrode Recording

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510(K) Number K965066
Device Name Catheter, Electrode Recording, Or Probe, Electrode Recording
Applicant CARDIAC PATHWAYS CORP.
995 BENECIA AVE.
SUNNYVALE, CA 94086 US
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Contact EARLE L CANTY
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Regulation Number 870.1220

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Classification Product Code DRF
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Date Received 12/18/1996
Decision Date 08/11/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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