510(k) K840046

PRESSURIZING/SCAVENGING ACRYLIC CEMENT by Precision Medical Devices, Inc. — Product Code KIH

K840046 is an FDA 510(k) premarket notification submitted by Precision Medical Devices, Inc. for the device "PRESSURIZING/SCAVENGING ACRYLIC CEMENT". The FDA issued a decision of Substantially Equivalent on February 9, 1984. The device falls under product code KIH (Dispenser, Cement), a Class I device regulated under 21 CFR 888.4200. Precision Medical Devices, Inc. has at least 2 other 510(k) clearances on record.