510(k) K091818

LAURIMED SPINAL INJECTION SYSTEM by Laurimed, LLC — Product Code BSP

K091818 is an FDA 510(k) premarket notification submitted by Laurimed, LLC for the device "LAURIMED SPINAL INJECTION SYSTEM". The FDA issued a decision of Substantially Equivalent on September 23, 2009. The device falls under product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)), a Class II device regulated under 21 CFR 868.5150. Laurimed, LLC has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2009
Date Received
June 18, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
Device Class
Class II
Regulation Number
868.5150
Review Panel
AN
Submission Type