510(k) K822411

SYSTEM 80 FACEPLATE-IN-THE-EAR #F1 by Western Advanced Technology, Inc. — Product Code EIB

K822411 is an FDA 510(k) premarket notification submitted by Western Advanced Technology, Inc. for the device "SYSTEM 80 FACEPLATE-IN-THE-EAR #F1". The FDA issued a decision of Substantially Equivalent on July 12, 1983. The device falls under product code EIB (Syringe, Irrigating (Dental)), a Class I device regulated under 21 CFR 872.4565. Western Advanced Technology, Inc. has at least 5 other 510(k) clearances on record.