510(k) K970882

ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.) by American Medical Devices, Inc. — Product Code MPA

K970882 is an FDA 510(k) premarket notification submitted by American Medical Devices, Inc. for the device "ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.)". The FDA issued a decision of Substantially Equivalent on June 24, 1997. The device falls under product code MPA (Endoilluminator), a Class II device regulated under 21 CFR 876.1500. American Medical Devices, Inc. has at least 5 other 510(k) clearances on record.