510(k) K973363

NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633 by Ml Strategies, Inc. — Product Code IWI

K973363 is an FDA 510(k) premarket notification submitted by Ml Strategies, Inc. for the device "NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633". The FDA issued a decision of Substantially Equivalent on July 2, 1998. The device falls under product code IWI (Source, Isotope, Sealed, Gold, Titanium, Platinum), a Class II device regulated under 21 CFR 892.5730. Ml Strategies, Inc. has at least 3 other 510(k) clearances on record.