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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cabinet,x-ray system
510(k) Number K122428
Device Name FAXITRON SPECIEN RADIOGRAPHY SYSTEM
Original Applicant
FAXITRON BIOPTICS LLC
3440 e. britannia drive
suite 150
tucson,  AZ  85706
Original Contact douglas c wiegman
Regulation Number892.1680
Classification Product Code
MWP  
Date Received08/09/2012
Decision Date 09/25/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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