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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Electrode Recording, Or Probe, Electrode Recording
510(k) Number K951347
Device Name MARINR SERIES EP DIAGNOSTI CATHETERS
Applicant
Medtronic Cardiorhythm
130 Rio Robles
San Jose,  CA  95134
Applicant Contact CRAIG J COOMBS
Correspondent
Medtronic Cardiorhythm
130 Rio Robles
San Jose,  CA  95134
Correspondent Contact CRAIG J COOMBS
Regulation Number870.1220
Classification Product Code
DRF  
Date Received02/28/1995
Decision Date 05/10/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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