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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 K120255
Model L30
Device Name PHILIPS MICRODOSE
Original Applicant
PHILIPS DIGITAL MAMMOGRAPHY SWEDEN AB
smidesvagen 5
solna,  SW se-171 41
Original Contact gustav lins
Regulation Number892.1715
Classification Product Code
MUE  
Date Received01/27/2012
Decision Date 04/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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