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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 K931193
Device Name SIM-400 SYSTEM
Applicant
Scinticor, Inc.
9051 W. Heather Ave.
Milwaukee,  WI  53224
Applicant Contact FRANCIS R CROTEAU
Correspondent
Scinticor, Inc.
9051 W. Heather Ave.
Milwaukee,  WI  53224
Correspondent Contact FRANCIS R CROTEAU
Regulation Number892.1200
Classification Product Code
KPS  
Date Received03/09/1993
Decision Date 06/21/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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