510(k) K834407

STERILE DISPOSABLE SPINAL NEEDLES by Hydro-Med Products, Inc. — Product Code FMI

K834407 is an FDA 510(k) premarket notification submitted by Hydro-Med Products, Inc. for the device "STERILE DISPOSABLE SPINAL NEEDLES". The FDA issued a decision of Substantially Equivalent on March 19, 1984. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Hydro-Med Products, Inc. has at least 10 other 510(k) clearances on record.