510(k) K973638

N.I.T., INC. NEEDLE GUIDING TEMPLATE by Avid N.I.T., Inc. — Product Code IWJ

K973638 is an FDA 510(k) premarket notification submitted by Avid N.I.T., Inc. for the device "N.I.T., INC. NEEDLE GUIDING TEMPLATE". The FDA issued a decision of Substantially Equivalent on December 23, 1997. The device falls under product code IWJ (System, Applicator, Radionuclide, Manual), a Class I device regulated under 21 CFR 892.5650. Avid N.I.T., Inc. has at least 8 other 510(k) clearances on record.