TROCHANTER MESH

Mesh, Surgical, Metal

ACUMED, INC.

The following data is part of a premarket notification filed by Acumed, Inc. with the FDA for Trochanter Mesh.

Pre-market Notification Details

Device IDK945027
510k NumberK945027
Device Name:TROCHANTER MESH
ClassificationMesh, Surgical, Metal
Applicant ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton,  OR  97005
ContactShari L Jeffers
CorrespondentShari L Jeffers
ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton,  OR  97005
Product CodeEZX  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-10-13
Decision Date1995-02-01

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