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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 K112111
Device Name ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR
Applicant
Acumed, LLC
5885 NW Cornelius Pass Rd.
Hillsboro,  OR  97124 -9432
Applicant Contact LINO TSAI
Correspondent
Acumed, LLC
5885 NW Cornelius Pass Rd.
Hillsboro,  OR  97124 -9432
Correspondent Contact LINO TSAI
Regulation Number888.3030
Classification Product Code
HTN  
Subsequent Product Codes
HRS   HWC   MBI  
Date Received07/25/2011
Decision Date 11/14/2011
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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