510(k) K821737

DISP. MICROSURGICAL KNIVES by Coburn Optical Ind., Inc. — Product Code GES

K821737 is an FDA 510(k) premarket notification submitted by Coburn Optical Ind., Inc. for the device "DISP. MICROSURGICAL KNIVES". The FDA issued a decision of Substantially Equivalent on July 2, 1982. The device falls under product code GES (Blade, Scalpel), a Class I device regulated under 21 CFR 878.4800. Coburn Optical Ind., Inc. has at least 10 other 510(k) clearances on record.