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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 K030594
Device Name I-125 RAPID STRAND, MODEL 7000
Applicant
Amersham Health
101 Carnegie Center
Princeton,  NJ  08540
Applicant Contact SUBHASH PATEL
Correspondent
Amersham Health
101 Carnegie Center
Princeton,  NJ  08540
Correspondent Contact SUBHASH PATEL
Regulation Number892.5730
Classification Product Code
KXK  
Date Received02/25/2003
Decision Date 04/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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