TRELEX NATURAL(R) MESH

Mesh, Surgical, Polymeric

MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.

The following data is part of a premarket notification filed by Meadox Medicals, Div. Boston Scientific Corp. with the FDA for Trelex Natural(r) Mesh.

Pre-market Notification Details

Device IDK945377
510k NumberK945377
Device Name:TRELEX NATURAL(R) MESH
ClassificationMesh, Surgical, Polymeric
Applicant MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 112 BAUER DR. Oakland,  NJ  07436
ContactSusan Eichler-houston
CorrespondentSusan Eichler-houston
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 112 BAUER DR. Oakland,  NJ  07436
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-10-24
Decision Date1994-12-08

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