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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 K112991
Device Name MODIFIED ROG SUTURE ANCHOR
Applicant
Rog Sports Medicine, Inc.
80 Shelton Technology Center
Shelton,  CT  06484
Applicant Contact CURTIS RAYMOND
Correspondent
Rog Sports Medicine, Inc.
80 Shelton Technology Center
Shelton,  CT  06484
Correspondent Contact CURTIS RAYMOND
Regulation Number888.3040
Classification Product Code
MBI  
Date Received10/06/2011
Decision Date 12/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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