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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 K942440
Device Name AFP CARDIAC PACING SYSTEM MODEL 283
Applicant
Siemens-Pacesetter, Inc.
15900 Valley View Ct.
Sylmar,  CA  91392
Applicant Contact NESTOR KUSIERZ
Correspondent
Siemens-Pacesetter, Inc.
15900 Valley View Ct.
Sylmar,  CA  91392
Correspondent Contact NESTOR KUSIERZ
Regulation Number870.3680
Classification Product Code
DTB  
Date Received05/20/1994
Decision Date 08/08/1994
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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