510(k) K883605

MODIFIED REUSABLE SITE FIBER OPTIC CABLE by Site Microsurgical Systems, Inc. — Product Code HQE

K883605 is an FDA 510(k) premarket notification submitted by Site Microsurgical Systems, Inc. for the device "MODIFIED REUSABLE SITE FIBER OPTIC CABLE". The FDA issued a decision of Substantially Equivalent on October 25, 1988. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. Site Microsurgical Systems, Inc. has at least 10 other 510(k) clearances on record.