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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K061440
Device Name P.D
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 Number892.5050
Classification Product Code
MUJ  
Date Received05/24/2006
Decision Date 06/27/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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