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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
Applicant
FAXITRON BIOPTICS LLC
3440 E. BRITANNIA DRIVE
SUITE 150
TUCSON,  AZ  85706
Applicant Contact DOUGLAS C WIEGMAN
Correspondent
FAXITRON BIOPTICS LLC
3440 E. BRITANNIA DRIVE
SUITE 150
TUCSON,  AZ  85706
Correspondent 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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