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FDA 510(k) Application Details - K000753
Device Classification Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
More FDA Info for this Device
510(K) Number
K000753
Device Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Applicant
CORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES, FL 33014 US
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Contact
ARIEL MACTAVISH
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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
03/08/2000
Decision Date
04/06/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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