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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Dose, Radionuclide
510(k) Number K013689
Device Name RE-ENTRANT CHAMBER
Applicant
Sun Nuclear Corp.
425-A Pineda Ct.
Melbourne,  FL  32940
Applicant Contact JIM MIXON
Correspondent
Sun Nuclear Corp.
425-A Pineda Ct.
Melbourne,  FL  32940
Correspondent Contact JIM MIXON
Regulation Number892.1360
Classification Product Code
KPT  
Date Received11/06/2001
Decision Date 07/02/2002
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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