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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 K990193
Device Name IODINE BRACHYTHERAPY SEEDS, MODEL 3000
Applicant
Implant Sciences Corp.
107 Audubon Rd., #5
Wakefield,  MA  01880
Applicant Contact HOWARD L SCHRAYER
Correspondent
Implant Sciences Corp.
107 Audubon Rd., #5
Wakefield,  MA  01880
Correspondent Contact HOWARD L SCHRAYER
Regulation Number892.5730
Classification Product Code
KXK  
Date Received01/21/1999
Decision Date 05/20/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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