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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 K162394
Device Name CRC-77tHR
Applicant
Capintec, Inc.
7 Vreeland Rd.
Florham Park,  NJ  07932
Applicant Contact Mary Anne Yusko
Correspondent
Capintec, Inc.
7 Vreeland Rd.
Florham Park,  NJ  07932
Correspondent Contact Mary Anne Yusko
Regulation Number892.1360
Classification Product Code
KPT  
Date Received08/26/2016
Decision Date 03/08/2017
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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