DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX

Suture, Surgical, Absorbable, Polydioxanone

COLOPLAST A/S

The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Digitex Suture Delivery System, Digitexpolypropylene Suture Cartridge Size 0, With Needle And Without Needle, Digitex.

Pre-market Notification Details

Device IDK120284
510k NumberK120284
Device Name:DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX
ClassificationSuture, Surgical, Absorbable, Polydioxanone
Applicant COLOPLAST A/S 1601 WEST RIVER ROAD NORTH Minneapolis,  MN  55411
ContactJanell Colley
CorrespondentJanell Colley
COLOPLAST A/S 1601 WEST RIVER ROAD NORTH Minneapolis,  MN  55411
Product CodeNEW  
CFR Regulation Number878.4840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-31
Decision Date2012-05-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05708932504089 K120284 000
05708932504058 K120284 000
05708932504027 K120284 000
05708932503990 K120284 000

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