Force Fiber Suture

Suture, Nonabsorbable, Synthetic, Polyethylene

Teleflex Medical Incorporated

The following data is part of a premarket notification filed by Teleflex Medical Incorporated with the FDA for Force Fiber Suture.

Pre-market Notification Details

Device IDK191268
510k NumberK191268
Device Name:Force Fiber Suture
ClassificationSuture, Nonabsorbable, Synthetic, Polyethylene
Applicant Teleflex Medical Incorporated 375 Forbes Boulevard Mansfield,  MA  02048
ContactAndrea Curria
CorrespondentAndrea Curria
Teleflex Medical Incorporated 375 Forbes Boulevard Mansfield,  MA  02048
Product CodeGAT  
CFR Regulation Number878.5000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-13
Decision Date2019-06-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.