510(k) K910980

SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE by Site Microsurgical Systems, Inc. — Product Code HJO

K910980 is an FDA 510(k) premarket notification submitted by Site Microsurgical Systems, Inc. for the device "SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE". The FDA issued a decision of Substantially Equivalent on May 22, 1991. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Site Microsurgical Systems, Inc. has at least 10 other 510(k) clearances on record.