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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cable, Transducer And Electrode, Patient, (Including Connector)
510(k) Number K010809
Device Name BIOCONNECT PATIENT MONITORING CABLES AND LEADWIRES, CAT# 1000 THRU CAT# 40000
Applicant
Rf Industries, Ltd.
541-A Birch St.
Lake Elsinore,  CA  92530
Applicant Contact DICK ROBERTS
Correspondent
Rf Industries, Ltd.
541-A Birch St.
Lake Elsinore,  CA  92530
Correspondent Contact DICK ROBERTS
Regulation Number870.2900
Classification Product Code
DSA  
Date Received03/16/2001
Decision Date 05/23/2001
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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