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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 K130269
Device Name ECAT SCINTRON PET
Applicant
Miegmbh
Hauptstrasse 112
Seth,  DE D-23845
Applicant Contact THOMAS KUEHL
Correspondent
Miegmbh
Hauptstrasse 112
Seth,  DE D-23845
Correspondent Contact THOMAS KUEHL
Regulation Number892.1200
Classification Product Code
KPS  
Date Received02/04/2013
Decision Date 04/19/2013
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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