LUPINE LOOP

Suture, Absorbable, Synthetic, Polyglycolic Acid

DEPUY MITEK, A JOHNSON & JOHNSON COMPANY

The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Lupine Loop.

Pre-market Notification Details

Device IDK050771
510k NumberK050771
Device Name:LUPINE LOOP
ClassificationSuture, Absorbable, Synthetic, Polyglycolic Acid
Applicant DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 249 VANDERBILT AVE. Norwood,  MA  02062
ContactDenise Luciano
CorrespondentDenise Luciano
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 249 VANDERBILT AVE. Norwood,  MA  02062
Product CodeGAM  
CFR Regulation Number878.4493 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-03-25
Decision Date2005-04-08
Summary:summary

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