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 Number | 878.3300
|
Classification Product Code |
|
Date Received | 11/17/2004 |
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
|
|
|