Filbloc

Suture, Surgical, Absorbable, Polydioxanone

ASSUT EUROPE

The following data is part of a premarket notification filed by Assut Europe with the FDA for Filbloc.

Pre-market Notification Details

Device IDK150553
510k NumberK150553
Device Name:Filbloc
ClassificationSuture, Surgical, Absorbable, Polydioxanone
Applicant ASSUT EUROPE ZONA INDUSTRIALE Magliano Dei Marsi,  IT 1-67062
ContactGloria Aggio
CorrespondentRhonda Alexander
REGISTRAR CORP 144 RESEARCH DRIVE Hampton,  VA  23666
Product CodeNEW  
CFR Regulation Number878.4840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-03-04
Decision Date2016-05-19
Summary:summary

NIH GUDID Devices

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Trademark Results [Filbloc]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FILBLOC
FILBLOC
79097329 4043866 Live/Registered
Assut Europe S.p.A.
2011-03-31

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