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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Dose, Radionuclide
510(k) Number K850838
Device Name CLINICOMP RDMS RADIONUCLIDE DISPENSING MGMT. SOFTW
Applicant
Clinicomp, Inc.
P.O. Box 7070
Huntington Woods,  MI  48070
Applicant Contact ALLEN GIGLIOTTI
Correspondent
Clinicomp, Inc.
P.O. Box 7070
Huntington Woods,  MI  48070
Correspondent Contact ALLEN GIGLIOTTI
Regulation Number892.1360
Classification Product Code
KPT  
Date Received03/01/1985
Decision Date 09/26/1985
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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