Nexus Suture

Suture, Nonabsorbable, Synthetic, Polyethylene

BAYLIS MEDICAL COMPANY INC.

The following data is part of a premarket notification filed by Baylis Medical Company Inc. with the FDA for Nexus Suture.

Pre-market Notification Details

Device IDK151009
510k NumberK151009
Device Name:Nexus Suture
ClassificationSuture, Nonabsorbable, Synthetic, Polyethylene
Applicant BAYLIS MEDICAL COMPANY INC. 2645 MATHESON BLVD. EAST Mississauga,  CA L4w 5s4
ContactMeghal Khakhar
CorrespondentMeghal Khakhar
BAYLIS MEDICAL COMPANY INC. 2645 MATHESON BLVD. EAST Mississauga,  CA L4w 5s4
Product CodeGAT  
CFR Regulation Number878.5000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-04-15
Decision Date2015-08-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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