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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K121284
Device Name CHABNER XRT GARMENTS
Applicant
BFFL CO. INC
600 NEW HAMPSHIRE AVENUE NW
SUITE 500
WASHINGTON,  DC  20037
Applicant Contact EVAN P PHELPS
Correspondent
BFFL CO. INC
600 NEW HAMPSHIRE AVENUE NW
SUITE 500
WASHINGTON,  DC  20037
Correspondent Contact EVAN P PHELPS
Regulation Number892.5050
Classification Product Code
IYE  
Date Received04/30/2012
Decision Date 06/14/2013
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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