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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K013334
Device Name ENDOFLIP
Applicant
Arthocare Corporation
38 Freemans Way
Harrogate, North Yorkshire,  GB HG3 2QF
Applicant Contact NICK WOODS
Correspondent
Arthocare Corporation
38 Freemans Way
Harrogate, North Yorkshire,  GB HG3 2QF
Correspondent Contact NICK WOODS
Regulation Number888.3040
Classification Product Code
MBI  
Date Received10/09/2001
Decision Date 12/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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