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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 K994317
Device Name I-PLANT, MODEL 3500
Applicant
IMPLANT SCIENCES CORP.
107 AUDUBON ROAD, #5
WAKEFIELD,  MA  01880 -1246
Applicant Contact HOWARD L SCHRAYER
Correspondent
IMPLANT SCIENCES CORP.
107 AUDUBON ROAD, #5
WAKEFIELD,  MA  01880 -1246
Correspondent Contact HOWARD L SCHRAYER
Regulation Number892.5730
Classification Product Code
KXK  
Date Received12/22/1999
Decision Date 03/21/2000
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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