BLUE ORTHOCORD SUTURE

Suture, Surgical, Absorbable, Polydioxanone

Depuy Mitek

The following data is part of a premarket notification filed by Depuy Mitek with the FDA for Blue Orthocord Suture.

Pre-market Notification Details

Device IDK043298
510k NumberK043298
Device Name:BLUE ORTHOCORD SUTURE
ClassificationSuture, Surgical, Absorbable, Polydioxanone
Applicant Depuy Mitek 249 VANDERBILT DR. Norwood,  MA  02062
ContactRuth C Forstadt
CorrespondentRuth C Forstadt
Depuy Mitek 249 VANDERBILT DR. Norwood,  MA  02062
Product CodeNEW  
CFR Regulation Number878.4840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-11-30
Decision Date2004-12-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20886705008848 K043298 000
20886705008831 K043298 000
20886705008817 K043298 000

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