510(k) K964910

AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTERLOADERS by Alpha-Omega Services, Inc. — Product Code JAQ

K964910 is an FDA 510(k) premarket notification submitted by Alpha-Omega Services, Inc. for the device "AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTERLOADERS". The FDA issued a decision of Substantially Equivalent on March 10, 1997. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Alpha-Omega Services, Inc. has at least 8 other 510(k) clearances on record.