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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full Field Digital, System, X-Ray, Mammographic
510(k) Number K110025
Device Name SECTRA MICRODOSE MAMMOGRAPHY
Applicant
Sectra Imtec AB
Teknikeingen 20
Linkoping,  SE 58330
Applicant Contact ALEXANDER ASKLOV
Correspondent
Sectra Imtec AB
Teknikeingen 20
Linkoping,  SE 58330
Correspondent Contact ALEXANDER ASKLOV
Regulation Number892.1715
Classification Product Code
MUE  
Date Received01/03/2011
Decision Date 04/28/2011
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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