510(k) K897045

BOWIE-DICK TEST CARD CATALOG NUMBER 008018 by Edward Weck, Inc. — Product Code JOJ

K897045 is an FDA 510(k) premarket notification submitted by Edward Weck, Inc. for the device "BOWIE-DICK TEST CARD CATALOG NUMBER 008018". The FDA issued a decision of Substantially Equivalent on February 15, 1990. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Edward Weck, Inc. has at least 10 other 510(k) clearances on record.