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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 K953255
Device Name NUQUEST NUCLEAR MEDICINE COMPUTER
Applicant
Sitco, Inc.
25663 Hillview Ct.
Mundelein,  IL  60060
Applicant Contact ROBERT H MCCARTHY
Correspondent
Sitco, Inc.
25663 Hillview Ct.
Mundelein,  IL  60060
Correspondent Contact ROBERT H MCCARTHY
Regulation Number892.1200
Classification Product Code
KPS  
Date Received07/12/1995
Decision Date 10/24/1995
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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