510(k) K972271

NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A by Ml Strategies, Inc. — Product Code KXK

K972271 is an FDA 510(k) premarket notification submitted by Ml Strategies, Inc. for the device "NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A". The FDA issued a decision of Substantially Equivalent on October 28, 1997. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. Ml Strategies, Inc. has at least 3 other 510(k) clearances on record.