510(k) K990646

PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE by Nsk Nakanishi, Inc. — Product Code EKX

K990646 is an FDA 510(k) premarket notification submitted by Nsk Nakanishi, Inc. for the device "PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE". The FDA issued a decision of Substantially Equivalent on March 19, 1999. The device falls under product code EKX (Handpiece, Direct Drive, Ac-Powered), a Class I device regulated under 21 CFR 872.4200. Nsk Nakanishi, Inc. has at least 10 other 510(k) clearances on record.