LIQUIBAND ULTIMA, MODEL LB0004

Tissue Adhesive For The Topical Approximation Of Skin

MEDLOGIC GLOBAL LTD.

The following data is part of a premarket notification filed by Medlogic Global Ltd. with the FDA for Liquiband Ultima, Model Lb0004.

Pre-market Notification Details

Device IDK083531
510k NumberK083531
Device Name:LIQUIBAND ULTIMA, MODEL LB0004
ClassificationTissue Adhesive For The Topical Approximation Of Skin
Applicant MEDLOGIC GLOBAL LTD. 5353 WAYZATA BLVD., SUITE 505 Minneapolis,  MN  55416
ContactTierney Norsted
CorrespondentTierney Norsted
MEDLOGIC GLOBAL LTD. 5353 WAYZATA BLVD., SUITE 505 Minneapolis,  MN  55416
Product CodeMPN  
CFR Regulation Number878.4010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-11-28
Decision Date2009-02-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05036912000871 K083531 000

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