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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 K080140
Device Name LAURIMED SPINAL INJECTION SYSTEM
Applicant
Laurimed, LLC
500 Arguello St., Suite 100
Redwood City,  CA  94063
Applicant Contact NANCY LINCE
Correspondent
Laurimed, LLC
500 Arguello St., Suite 100
Redwood City,  CA  94063
Correspondent Contact NANCY LINCE
Regulation Number868.5150
Classification Product Code
BSP  
Date Received01/22/2008
Decision Date 05/09/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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