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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 Dr., Suite 150
Tucson,  AZ  85706
Applicant Contact DOUGLAS C WIEGMAN
Correspondent
Faxitron Bioptics, LLC
3440 E. Britannia Dr., 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
Predetermined Change
Control Plan Authorized		 No
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