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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 K954551
Device Name DF-1 TERMINAL CAP
Applicant
Pacesetter, Inc.
15900 Vaklley View Ct.
Sylmar,  CA  91342
Applicant Contact JACQUELINE J JACKSON
Correspondent
Pacesetter, Inc.
15900 Vaklley View Ct.
Sylmar,  CA  91342
Correspondent Contact JACQUELINE J JACKSON
Regulation Number870.3680
Classification Product Code
DTB  
Date Received10/02/1995
Decision Date 12/26/1995
Decision SE SUBJECT TO TRACKING REG (ST)
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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