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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Washer, Bolt Nut
510(k) Number K133835
Device Name ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM
Applicant
Arthrosurface, Inc.
28 Forge Pkwy.
Franklin,  MA  02038
Applicant Contact DAWN J WILSON
Correspondent
Arthrosurface, Inc.
28 Forge Pkwy.
Franklin,  MA  02038
Correspondent Contact DAWN J WILSON
Regulation Number888.3030
Classification Product Code
HTN  
Date Received12/18/2013
Decision Date 07/03/2014
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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