510(k) K924277

DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING by Chalgren Enterprises, Inc. — Product Code HLT

K924277 is an FDA 510(k) premarket notification submitted by Chalgren Enterprises, Inc. for the device "DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING". The FDA issued a decision of Substantially Equivalent on December 7, 1994. The device falls under product code HLT (Preamplifier, Ac-Powered, Ophthalmic), a Class II device regulated under 21 CFR 886.1640. Chalgren Enterprises, Inc. has at least 10 other 510(k) clearances on record.