510(k) K834354

OPHTEC RUST RING REMOVER by Jedmed Instrument Co. — Product Code HOG

K834354 is an FDA 510(k) premarket notification submitted by Jedmed Instrument Co. for the device "OPHTEC RUST RING REMOVER". The FDA issued a decision of Substantially Equivalent on March 19, 1984. The device falls under product code HOG (Burr, Corneal, Battery-Powered), a Class I device regulated under 21 CFR 886.4070. Jedmed Instrument Co. has at least 10 other 510(k) clearances on record.