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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K970970
Device Name CARDIOMATCH
Applicant
Focus Medical SA
70 Walnut St.
Wellesley,  MA  02181
Applicant Contact JEAN-LUC BOULNOIS
Correspondent
Focus Medical SA
70 Walnut St.
Wellesley,  MA  02181
Correspondent Contact JEAN-LUC BOULNOIS
Regulation Number892.1200
Classification Product Code
KPS  
Date Received03/17/1997
Decision Date 06/13/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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