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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 K133469
Device Name ACUMED SUTURE ANCHOR SYSTEM
Applicant
Acumed, LLC
5885 NW Cornelius Pass Rd.
Hillsboro,  OR  97124
Applicant Contact LINO TSAI
Correspondent
Acumed, LLC
5885 NW Cornelius Pass Rd.
Hillsboro,  OR  97124
Correspondent Contact LINO TSAI
Regulation Number888.3040
Classification Product Code
MBI  
Date Received11/12/2013
Decision Date 03/10/2014
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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