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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K010449
Device Name IVD (IN VIVO DOSIMETER), MODEL 1131
Applicant
Sun Nuclear Corp.
425-A Pineda Ct.
Melbourne,  FL  32940
Applicant Contact NOEL M DOWNEY
Correspondent
Sun Nuclear Corp.
425-A Pineda Ct.
Melbourne,  FL  32940
Correspondent Contact NOEL M DOWNEY
Regulation Number892.5050
Classification Product Code
IYE  
Date Received02/15/2001
Decision Date 05/04/2001
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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