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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Isotope, Sealed, Gold, Titanium, Platinum
510(k) Number K973363
Device Name NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633
Applicant
ML STRATEGIES, INC.
ONE FINANCIAL CENTER
BOSTON,  MA  02111
Applicant Contact ALLAN M GREEN
Correspondent
ML STRATEGIES, INC.
ONE FINANCIAL CENTER
BOSTON,  MA  02111
Correspondent Contact ALLAN M GREEN
Regulation Number892.5730
Classification Product Code
IWI  
Subsequent Product Code
KXK  
Date Received09/08/1997
Decision Date 07/02/1998
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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