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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 K141413
Device Name CRC PC WITH SMART CHAMBER
Applicant
Capintec, Inc.
620 Alpha Dr.
Pittsburgh,  PA  15241
Applicant Contact MARY ANNE YUSKO
Correspondent
Capintec, Inc.
620 Alpha Dr.
Pittsburgh,  PA  15241
Correspondent Contact MARY ANNE YUSKO
Regulation Number892.1360
Classification Product Code
KPT  
Date Received05/29/2014
Decision Date 06/27/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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