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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 K023242
Device Name I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE
Applicant
Implant Sciences Corp.
107 Audubon Rd., #5
Wakefield,  MA  01880
Applicant Contact JEFFREY GIBBS
Correspondent
Implant Sciences Corp.
107 Audubon Rd., #5
Wakefield,  MA  01880
Correspondent Contact JEFFREY GIBBS
Regulation Number892.5730
Classification Product Code
KXK  
Date Received09/30/2002
Decision Date 12/04/2002
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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