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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical
510(k) Number K112786
Device Name PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF
Applicant
SYNOVIS ORTHOPEDIC AND WOUNDCARE, INC.
6 JENNER
SUITE 150
IRVINE,  CA  92618
Applicant Contact AMY BOUCLY
Correspondent
SYNOVIS ORTHOPEDIC AND WOUNDCARE, INC.
6 JENNER
SUITE 150
IRVINE,  CA  92618
Correspondent Contact AMY BOUCLY
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Code
FTL  
Date Received09/26/2011
Decision Date 10/25/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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