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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 K954714
Device Name AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION)
Applicant
Pacesetter, Inc.
15900 Valley View Ct.
P O Box 9221
Sylmar,  CA  91342
Applicant Contact PAUL MASON
Correspondent
Pacesetter, Inc.
15900 Valley View Ct.
P O Box 9221
Sylmar,  CA  91342
Correspondent Contact PAUL MASON
Regulation Number870.3680
Classification Product Code
DTB  
Date Received10/02/1995
Decision Date 02/01/1996
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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