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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 K071077
Device Name .DECIMAL APERTURE
Applicant
.DECIMAL, INC.
121 CENTRAL PARK PLACE
SANFORD,  FL  32771
Applicant Contact DANIEL BENNETT
Correspondent
.DECIMAL, INC.
121 CENTRAL PARK PLACE
SANFORD,  FL  32771
Correspondent Contact DANIEL BENNETT
Regulation Number892.5710
Classification Product Code
IXI  
Date Received04/17/2007
Decision Date 05/18/2007
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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