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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 PLACE
CHARLOTTE,  NC  28262
Applicant Contact SHOSH FRIEDMAN
Correspondent
SURGICAL STRUCTURES LTD.
1914 J.N. PEASE PLACE
CHARLOTTE,  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
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