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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 K111759
Device Name .DECIMAL ELECTRON APERTURE
Applicant
.Decimal, Inc.
121 Central Park Pl.
Sanford,  FL  32771
Applicant Contact DANIEL L BENNETT
Correspondent
.Decimal, Inc.
121 Central Park Pl.
Sanford,  FL  32771
Correspondent Contact DANIEL L BENNETT
Regulation Number892.5710
Classification Product Code
IXI  
Date Received06/22/2011
Decision Date 09/09/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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