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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 K040804
Device Name .DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR
Applicant
Southeastern Radiation Products, Inc.
2651 N. Design Ct.
Sanford,  FL  32773
Applicant Contact RICHARD SWEAT
Correspondent
Southeastern Radiation Products, Inc.
2651 N. Design Ct.
Sanford,  FL  32773
Correspondent Contact RICHARD SWEAT
Regulation Number892.5710
Classification Product Code
IXI  
Date Received03/29/2004
Decision Date 04/28/2004
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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