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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
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