510(k) K023838

LUNEAU STERILE TONOMETER SEPARATION PRISMS by Luneau SA — Product Code HKY

K023838 is an FDA 510(k) premarket notification submitted by Luneau SA for the device "LUNEAU STERILE TONOMETER SEPARATION PRISMS". The FDA issued a decision of Substantially Equivalent on February 20, 2003. The device falls under product code HKY (Tonometer, Manual), a Class II device regulated under 21 CFR 886.1930. Luneau SA has at least 4 other 510(k) clearances on record.