510(k) K972443

MENICON SF-P AND MENICON Z RIGID GAS PERMEABLE CONTACT LENS by Menicon U.S.A., Inc. — Product Code HQD

K972443 is an FDA 510(k) premarket notification submitted by Menicon U.S.A., Inc. for the device "MENICON SF-P AND MENICON Z RIGID GAS PERMEABLE CONTACT LENS". The FDA issued a decision of Substantially Equivalent on Aug 22, 1997. The device falls under product code HQD (Lens, Contact (Other Material) - Daily), a Class II device regulated under 21 CFR 886.5916. Menicon U.S.A., Inc. has 2 other 510(k) clearances on record.