PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE

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 Passing Needle With Ethibond, Panacryl Or Orthocord Suture.

Pre-market Notification Details

Device IDK042233
510k NumberK042233
Device Name:PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE
ClassificationSuture, Absorbable, Synthetic, Polyglycolic Acid
Applicant DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 249 VANDERBILT AVE. Norwood,  MA  02062
ContactRuth C Forstadt
CorrespondentRuth C Forstadt
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 249 VANDERBILT AVE. Norwood,  MA  02062
Product CodeGAM  
Subsequent Product CodeGAT
Subsequent Product CodeNEW
CFR Regulation Number878.4493 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-08-18
Decision Date2004-09-28
Summary:summary

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