510(k) K983621

NEEDLE GUIDE by Remington Medical, Inc. — Product Code IZH

K983621 is an FDA 510(k) premarket notification submitted by Remington Medical, Inc. for the device "NEEDLE GUIDE". The FDA issued a decision of Substantially Equivalent on November 3, 1998. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Remington Medical, Inc. has at least 10 other 510(k) clearances on record.