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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 K992963
Device Name I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401
Applicant
International Isotopes, Inc.
3100 Jim Christal Rd.
Denton,  TX  76207 -2600
Applicant Contact REBECCA ELLIS
Correspondent
International Isotopes, Inc.
3100 Jim Christal Rd.
Denton,  TX  76207 -2600
Correspondent Contact REBECCA ELLIS
Regulation Number892.5730
Classification Product Code
KXK  
Date Received09/02/1999
Decision Date 09/21/1999
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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