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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 K943257
Device Name TIP DEFLECTOR (GENESIS)
Applicant
ELECTRO-CATHETER CORP.
2100 FELVER CT.
RAHWAY,  NJ  07065
Applicant Contact LORRAINE T MONTEMURRO
Correspondent
ELECTRO-CATHETER CORP.
2100 FELVER CT.
RAHWAY,  NJ  07065
Correspondent Contact LORRAINE T MONTEMURRO
Regulation Number870.1220
Classification Product Code
DRF  
Date Received07/06/1994
Decision Date 04/19/1995
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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