510(k) K991418

BROWNE MVI ETHYLENE OXIDE INDICATOR by Albert Browne , Ltd. — Product Code JOJ

K991418 is an FDA 510(k) premarket notification submitted by Albert Browne , Ltd. for the device "BROWNE MVI ETHYLENE OXIDE INDICATOR". The FDA issued a decision of Substantially Equivalent on June 10, 1999. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Albert Browne , Ltd. has at least 10 other 510(k) clearances on record.