510(k) K061394

SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE) by Busse Hospital Disposables, Inc. — Product Code BSP

K061394 is an FDA 510(k) premarket notification submitted by Busse Hospital Disposables, Inc. for the device "SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE)". The FDA issued a decision of Substantially Equivalent on September 6, 2006. The device falls under product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)), a Class II device regulated under 21 CFR 868.5150. Busse Hospital Disposables, Inc. has at least 10 other 510(k) clearances on record.