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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 K981642
Device Name STABLEMAPR STEERABLE INTRACARDIAC CATHETERS
Applicant
Medtronic Cardiorhythm
1312 Crossman Ave.
Sunnyvale,  CA  94089 -1113
Applicant Contact KRISTEN HONL
Correspondent
Medtronic Cardiorhythm
1312 Crossman Ave.
Sunnyvale,  CA  94089 -1113
Correspondent Contact KRISTEN HONL
Regulation Number870.1220
Classification Product Code
DRF  
Date Received05/08/1998
Decision Date 08/05/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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