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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Brachytherapy, Radionuclide
510(k) Number K002446
Device Name RE-ENTRANT CHAMBER, MODEL 1008 OR 44D
Applicant
Sun Nuclear Corp.
425-A Pineda Court
Melbourne,  FL  32940
Applicant Contact THOMAS L POWERS
Correspondent
Sun Nuclear Corp.
425-A Pineda Court
Melbourne,  FL  32940
Correspondent Contact THOMAS L POWERS
Regulation Number892.5730
Classification Product Code
KXK  
Subsequent Product Code
JAQ  
Date Received08/09/2000
Decision Date 10/23/2000
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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