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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 K091911
Device Name BOLUS COMPENSATOR
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 Received06/25/2009
Decision Date 07/21/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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