510(k) K970670

REUSABLE VITRECTOMY PROBE by Altex Vision — Product Code HQE

K970670 is an FDA 510(k) premarket notification submitted by Altex Vision for the device "REUSABLE VITRECTOMY PROBE". The FDA issued a decision of Substantially Equivalent on May 6, 1997. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. Altex Vision has at least 1 other 510(k) clearance on record.