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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 K113460
Device Name SYNERGY TISSUE MATRIX
Applicant
SYNOVIS ORTHOPEDIC & WOUNDCARE
6 Jenner, Suite 150
IRVINE,  CA  92618
Applicant Contact AMY BOUCLY
Correspondent
SYNOVIS ORTHOPEDIC & WOUNDCARE
6 Jenner, Suite 150
IRVINE,  CA  92618
Correspondent Contact AMY BOUCLY
Regulation Number878.3300
Classification Product Code
FTM  
Date Received11/22/2011
Decision Date 01/11/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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