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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 K913375
Device Name TORQUE TUBE STEEROCATH(TM)
Applicant
Ep Technologies, Inc.
897 Independence Ave. Suite 1-
D
Mountain View,  CA  94043
Applicant Contact LINDA COOPERMAN
Correspondent
Ep Technologies, Inc.
897 Independence Ave. Suite 1-
D
Mountain View,  CA  94043
Correspondent Contact LINDA COOPERMAN
Regulation Number870.1220
Classification Product Code
DRF  
Date Received07/29/1991
Decision Date 10/25/1991
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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