FDA 510(k) Application Details - K953663

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

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510(K) Number K953663
Device Name Catheter, Electrode Recording, Or Probe, Electrode Recording
Applicant CORDIS WEBSTER, INC.
4750 LITTLEJOHN ST.
BALDWIN PARK, CA 91706 US
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Contact MARY ADAMS
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Regulation Number 870.1220

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Classification Product Code DRF
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Date Received 08/07/1995
Decision Date 09/18/1996
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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