510(k) K852014

EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA by Effner and Spreine Co. — Product Code KOA

K852014 is an FDA 510(k) premarket notification submitted by Effner and Spreine Co. for the device "EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA". The FDA issued a decision of Substantially Equivalent on August 7, 1985. The device falls under product code KOA (Surgical Instruments, G-U, Manual (And Accessories)), a Class I device regulated under 21 CFR 876.4730. Effner and Spreine Co. has at least 3 other 510(k) clearances on record.