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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Permanent Pacemaker Electrode
510(k) Number K850065
Device Name ELECATH TORKFLOAT PACING PROBE
Applicant
Electro-Catheter Corp.
2100 Felver Court
P.O. Box 1214c
Rahway,  NJ  07065
Applicant Contact TERY M SILPE
Correspondent
Electro-Catheter Corp.
2100 Felver Court
P.O. Box 1214c
Rahway,  NJ  07065
Correspondent Contact TERY M SILPE
Regulation Number870.3680
Classification Product Code
DTB  
Date Received01/08/1985
Decision Date 04/10/1985
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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