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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implantable Pacemaker Pulse-Generator
510(k) Number K946188
Device Name CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER
Applicant
Cardiac Control Systems, Inc.
3 Commerce Blvd.
Palm Coast,  FL  32164
Applicant Contact TERRY C MCMAHON
Correspondent
Cardiac Control Systems, Inc.
3 Commerce Blvd.
Palm Coast,  FL  32164
Correspondent Contact TERRY C MCMAHON
Regulation Number870.3610
Classification Product Code
DXY  
Date Received12/20/1994
Decision Date 05/15/1995
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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