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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K082194
Device Name LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002
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 Number888.1100
Classification Product Code
HRX  
Date Received08/04/2008
Decision Date 08/28/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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