DYNATAPE Suture

Suture, Nonabsorbable, Synthetic, Polyethylene

Medos International SARL

The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Dynatape Suture.

Pre-market Notification Details

Device IDK203186
510k NumberK203186
Device Name:DYNATAPE Suture
ClassificationSuture, Nonabsorbable, Synthetic, Polyethylene
Applicant Medos International SARL Chemin-Blanc 38, Case Postale Le Locle,  CH Ch 2400
ContactTatyana Korsunsky
CorrespondentTatyana Korsunsky
DePuy Mitek, A Johnson And Johnson Company 325 Paramount Drive Raynham,  MA  02767
Product CodeGAT  
CFR Regulation Number878.5000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-27
Decision Date2021-03-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886705031191 K203186 000
10886705031184 K203186 000

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