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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 K052024
Device Name NSTRAND IMPLANTATION KIT
Applicant
North American Scientific, Inc.
20200 Sunburst St.
Chatsworth,  CA  91311
Applicant Contact LEIGH SPOTTEN
Correspondent
North American Scientific, Inc.
20200 Sunburst St.
Chatsworth,  CA  91311
Correspondent Contact LEIGH SPOTTEN
Regulation Number892.5730
Classification Product Code
KXK  
Date Received07/26/2005
Decision Date 09/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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