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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, Polymeric
510(k) Number K043191
Device Name REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH
Applicant
Angiologica B. M. Srl
4, Via Giovanni Xxiii
San Martino Siccomario, Pavia,  IT 27028
Applicant Contact ROBERTO MANCA
Correspondent
Angiologica B. M. Srl
4, Via Giovanni Xxiii
San Martino Siccomario, Pavia,  IT 27028
Correspondent Contact ROBERTO MANCA
Regulation Number878.3300
Classification Product Code
FTL  
Date Received11/17/2004
Decision Date 05/16/2005
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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