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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 K961118
Device Name MAXIM PF MODELS 033-581/033-590
Applicant
Telectronics Pacing Systems, Inc.
7400 S. Tucson Way
Englewood,  CO  80112
Applicant Contact ANDREW CLEELAND
Correspondent
Telectronics Pacing Systems, Inc.
7400 S. Tucson Way
Englewood,  CO  80112
Correspondent Contact ANDREW CLEELAND
Regulation Number870.3680
Classification Product Code
DTB  
Date Received03/20/1996
Decision Date 07/15/1996
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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