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510(k) Data Aggregation
K Number
K070625Device Name
PELVIMESH / HERMESH 7
Manufacturer
MARKETING SOLUTIONS INC.
Date Cleared
2007-08-01
(148 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
MARKETING SOLUTIONS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hermesh 7 monofilament polypropylene mesh may be used for repair of abdominal wall hernia, including inguinal, femoral, and incisional, in open or laparoscopic abdominal procedures.
Device Description
Hermesh 7 prosthesis are non- absorbable monofilament polypropylene meshes constructed from knitted monofilaments of extruded polypropylene. They are warp knitted in such a way that the mesh may be cut into preshaped designs without unraveling. They maintain excellent isotropic properties because of its knitted construction. Hermesh 7 polypropylene meshes have the necessary strength, flexibility, and durability for the various stresses which may be encountered in the body. The devices are supplied as sterile, single-use surgical meshes.
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