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K Number
K954665

Validate with FDA (Live)

Device Name
GLYCAR STAPLE STRIPS
Manufacturer
GLYCAR, INC.
Date Cleared
1996-02-14

(127 days)

Product Code
FTL
Regulation Number
878.3300
Type
Traditional
Panel
General & Plastic Surgery
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K992159
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis 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.