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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Radiation Therapy, Radionuclide
510(k) Number K925133
Device Name DPD-510 THERAPEUTIC RADIATION DOSIMETER
Applicant
Scanditronix, Inc.
Husbyborg, S-752 29
Uppsala
Sweden,  SE
Applicant Contact LENNART WARD
Correspondent
Scanditronix, Inc.
Husbyborg, S-752 29
Uppsala
Sweden,  SE
Correspondent Contact LENNART WARD
Regulation Number892.5750
Classification Product Code
IWB  
Date Received10/13/1992
Decision Date 01/04/1993
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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