ENDOBUTTON CONTINUOUS LOOP

Suture, Nonabsorbable, Synthetic, Polyethylene

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Endobutton Continuous Loop.

Pre-market Notification Details

Device IDK980155
510k NumberK980155
Device Name:ENDOBUTTON CONTINUOUS LOOP
ClassificationSuture, Nonabsorbable, Synthetic, Polyethylene
Applicant SMITH & NEPHEW, INC. 130 FORBES BLVD. Mansfield,  MA  02048
ContactDemetrios Tsakonas
CorrespondentDemetrios Tsakonas
SMITH & NEPHEW, INC. 130 FORBES BLVD. Mansfield,  MA  02048
Product CodeGAT  
CFR Regulation Number878.5000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-01-16
Decision Date1998-04-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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