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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 K013598
Device Name REUSE CLAIM FOR THE BARD ELECTROPHYSIOLOGY SURELINK, TEMPLINK, AND TEMPLINK M EXTENSION CABLES
Applicant
C.R. Bard, Inc.
55 Technology Dr.
Lowell,  MA  01851
Applicant Contact EBORAH L HERRINGTON
Correspondent
C.R. Bard, Inc.
55 Technology Dr.
Lowell,  MA  01851
Correspondent Contact EBORAH L HERRINGTON
Regulation Number870.2900
Classification Product Code
DSA  
Date Received10/31/2001
Decision Date 01/11/2002
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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