510(k) K032801

MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR by Albert Browne , Ltd. — Product Code JOJ

K032801 is an FDA 510(k) premarket notification submitted by Albert Browne , Ltd. for the device "MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR". The FDA issued a decision of Substantially Equivalent on October 17, 2003. 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.