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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K990734
Device Name DPD-12PCC
Applicant
Scanditronix Medical AB
Stalgatan 14
Uppsala S-754 50,  SE S-754 50
Applicant Contact EVA LARSTEN
Correspondent
Scanditronix Medical AB
Stalgatan 14
Uppsala S-754 50,  SE S-754 50
Correspondent Contact EVA LARSTEN
Regulation Number892.5050
Classification Product Code
IYE  
Date Received03/05/1999
Decision Date 05/28/1999
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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