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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name filler, bone void, calcium compound
510(k) Number K173008
Device Name SCS 17-01
Anika Therapeutics, Inc.
32 Wiggins Avenue
Bedford,  MA  01730
Applicant Contact Steven Chartier
Musculoskeletal Clinical Regulatory Advisers, LLC
32 Wiggins Avenue
Bedford,  MA  01730
Correspondent Contact Steven Chartier
Regulation Number888.3045
Classification Product Code
Date Received09/27/2017
Decision Date 12/26/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No