LINK ACETABULAR MESH

Mesh, Surgical

WALDEMAR LINK GMBH & CO. KG

The following data is part of a premarket notification filed by Waldemar Link Gmbh & Co. Kg with the FDA for Link Acetabular Mesh.

Pre-market Notification Details

Device IDK844225
510k NumberK844225
Device Name:LINK ACETABULAR MESH
ClassificationMesh, Surgical
Applicant WALDEMAR LINK GMBH & CO. KG 10 GREAT MEADOW LN. E. Hanover,  NJ  07936
ContactEd Schussler
CorrespondentEd Schussler
WALDEMAR LINK GMBH & CO. KG 10 GREAT MEADOW LN. E. Hanover,  NJ  07936
Product CodeFTM  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-11-01
Decision Date1984-11-14

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