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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pacemaker Lead Adaptor
510(k) Number K950140
Device Name IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069
Applicant
Pacesetter, Inc.
15900 Vaklley View Ct.
Sylmar,  CA  91342
Applicant Contact PAUL MASON
Correspondent
Pacesetter, Inc.
15900 Vaklley View Ct.
Sylmar,  CA  91342
Correspondent Contact PAUL MASON
Regulation Number870.3620
Classification Product Code
DTD  
Date Received01/13/1995
Decision Date 04/06/1995
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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