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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Applicator, Radionuclide, Manual
510(k) Number K951052
Device Name WEEKS APPLICATOR
Applicant
Duke University Medical Center
Box 3010
Duke University Medical Center
Durham,  NC  27710
Applicant Contact KENNETH J WEEKS
Correspondent
Duke University Medical Center
Box 3010
Duke University Medical Center
Durham,  NC  27710
Correspondent Contact KENNETH J WEEKS
Regulation Number892.5650
Classification Product Code
IWJ  
Date Received03/06/1995
Decision Date 08/22/1996
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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