REFINE SUPPORT SYSTEM, MODEL 100.0100

Mesh, Surgical, Polymeric

ALURE MEDICAL INC.

The following data is part of a premarket notification filed by Alure Medical Inc. with the FDA for Refine Support System, Model 100.0100.

Pre-market Notification Details

Device IDK092538
510k NumberK092538
Device Name:REFINE SUPPORT SYSTEM, MODEL 100.0100
ClassificationMesh, Surgical, Polymeric
Applicant ALURE MEDICAL INC. 3637 WESTWIND BLVD., SUITE B Santa Rosa,  CA  95403
ContactJoseph Tamayo
CorrespondentJoseph Tamayo
ALURE MEDICAL INC. 3637 WESTWIND BLVD., SUITE B Santa Rosa,  CA  95403
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-08-19
Decision Date2010-03-05
Summary:summary

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