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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, Deployment Balloon
510(k) Number K092726
Device Name MESH GPS - LARGE, SMALL, SM, SM SMALL
Applicant
Surgical Structures , Ltd.
1914 J.N. Pease Pl.
Chalotte,  NC  28262
Applicant Contact SHOSH FRIEDMAN
Correspondent
Surgical Structures , Ltd.
1914 J.N. Pease Pl.
Chalotte,  NC  28262
Correspondent Contact SHOSH FRIEDMAN
Regulation Number878.3300
Classification Product Code
OQL  
Subsequent Product Code
GCJ  
Date Received09/03/2009
Decision Date 03/15/2010
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
Predetermined Change
Control Plan Authorized		 No
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