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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 K042864
Device Name IMPLANT SCIENCES CORP, MODEL HDR-4140
Applicant
Implant Sciences Corp.
107 Audubon Rd., #5
Wakefield,  MA  01880
Applicant Contact JOHN J MUNRO
Correspondent
Implant Sciences Corp.
107 Audubon Rd., #5
Wakefield,  MA  01880
Correspondent Contact JOHN J MUNRO
Regulation Number892.5730
Classification Product Code
KXK  
Date Received10/18/2004
Decision Date 01/06/2005
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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