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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 K811320
Device Name CAL-3 CALIBRATED RADIOACTIVITY ASSAYER
Applicant
Dosimeter Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Dosimeter Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number892.1360
Classification Product Code
KPT  
Date Received05/12/1981
Decision Date 06/02/1981
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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