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510(k) K083909

SPINAL INJECTION SYSTEM by Laurimed, LLC — Product Code BSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2009
Date Received
December 30, 2008
Clearance Type
Traditional
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

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  • K133133 — LAURIMED POLYPVAC MICRODEBRIDER (December 23, 2013)
  • K091818 — LAURIMED SPINAL INJECTION SYSTEM (September 23, 2009)
  • K090815 — PERCUTANEOUS DISCECTOMY SYSTEM (May 21, 2009)
  • K082194 — LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002 (August 28, 2008)
  • K080140 — LAURIMED SPINAL INJECTION SYSTEM (May 9, 2008)

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