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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pulse-Generator, Pacemaker, External
510(k) Number K023080
Device Name GALIX PACESTAR
Applicant
Galix Biomedical Instrumentation, Inc.
2555 Collins Ave., C-5
Miami Beach,  FL  33140
Applicant Contact JORDAN GAVRIELIDES
Correspondent
Galix Biomedical Instrumentation, Inc.
2555 Collins Ave., C-5
Miami Beach,  FL  33140
Correspondent Contact JORDAN GAVRIELIDES
Regulation Number870.3600
Classification Product Code
DTE  
Date Received09/17/2002
Decision Date 06/11/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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