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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name block, beam-shaping, radiation therapy
510(k) Number K090417
Device Name AXXENT FLEXISHIELD MINI
Applicant
XOFT, INC.
345 POTRERO AVE.
SUNNYVALE,  CA  94085
Applicant Contact STEVE LIN
Correspondent
XOFT, INC.
345 POTRERO AVE.
SUNNYVALE,  CA  94085
Correspondent Contact STEVE LIN
Regulation Number892.5710
Classification Product Code
IXI  
Date Received02/18/2009
Decision Date 06/23/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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