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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Conduction, Anesthetic (W/Wo Introducer)
510(k) Number K091818
Device Name LAURIMED SPINAL INJECTION SYSTEM
Applicant
Laurimed, LLC
500 Arguello St., Suite 100
Redwood City,  CA  94063
Applicant Contact SEVRINA CIUCCI
Correspondent
Laurimed, LLC
500 Arguello St., Suite 100
Redwood City,  CA  94063
Correspondent Contact SEVRINA CIUCCI
Regulation Number868.5150
Classification Product Code
BSP  
Date Received06/18/2009
Decision Date 09/23/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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