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K Number
K072962
Device Name
CABS'AIR
Manufacturer
COUSIN BIOTECH S.A.S.
Date Cleared
2008-06-26

(251 days)

Product Code
FTL
Regulation Number
878.3300
Type
Traditional
Panel
General & Plastic Surgery
Reference & Predicate Devices
N/A
Predicate For
K092726,K093196
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.