PTFE SURGICAL SUTURE

Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

OMNIA SPA

The following data is part of a premarket notification filed by Omnia Spa with the FDA for Ptfe Surgical Suture.

Pre-market Notification Details

Device IDK132464
510k NumberK132464
Device Name:PTFE SURGICAL SUTURE
ClassificationSuture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Applicant OMNIA SPA VIA SARAGAT 5 Imola, Bo,  IT 40026
ContactMarco Manduchi
CorrespondentMarco Manduchi
OMNIA SPA VIA SARAGAT 5 Imola, Bo,  IT 40026
Product CodeNBY  
CFR Regulation Number878.5035 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-07
Decision Date2014-02-12

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