LS-5 EPTFE Suture

Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

LSI SOLUTIONS

The following data is part of a premarket notification filed by Lsi Solutions with the FDA for Ls-5 Eptfe Suture.

Pre-market Notification Details

Device IDK163639
510k NumberK163639
Device Name:LS-5 EPTFE Suture
ClassificationSuture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Applicant LSI SOLUTIONS 7796 VICTOR-MENDON RD Victor,  NY  14564
ContactKevin Bentley
CorrespondentKevin Bentley
LSI SOLUTIONS 7796 VICTOR-MENDON RD Victor,  NY  14564
Product CodeNBY  
CFR Regulation Number878.5035 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-23
Decision Date2017-06-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10850200006428 K163639 000

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