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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 K030066
Device Name CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165
Applicant
Nuclear Associates
120 Andrews Rd.
Hicksville,  NY  11801
Applicant Contact CHRISTINE G CASTLEBERRY
Correspondent
Nuclear Associates
120 Andrews Rd.
Hicksville,  NY  11801
Correspondent Contact CHRISTINE G CASTLEBERRY
Regulation Number892.1360
Classification Product Code
KPT  
Date Received01/07/2003
Decision Date 08/29/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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