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510(k) K181578

Device
DemeTECH PTFE Nonabsorbable Surgical Suture
Applicant
Demetech Corporation
510(k) number
K181578
Product code
NBY  
Decision
Substantially Equivalent (SESE)
Decision date
2018-10-11
Date received
2018-06-15
Regulation
878.5035
Classification name
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Linda Hernandez
Address
14175 NW 60th Ave. Miami Lakes FL US 33104 33104

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NBY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K231277TissueStatDurastat, LLC2023-11-09
K192088GOLNIT Non-aborbable PTFE Surgical SutureAntarma, LLC Dba Golnit Sutures2019-09-04
K180992BiotexPurgo Biologics, Inc.2019-07-16
K191317StitchKitOrigami Surgical2019-07-12
K180630PTFE SURGICAL SUTUREOmnia Spa2018-04-06
K173922C-PTFETM Surgical SutureCp Medical, Inc.2018-03-26
K173335Gazelle PTFE and Suture Delivery DeviceDura Tap, LLC2018-02-08
K170842WEGO-PTFEFoosin Medical Supplies Inc., Ltd.2017-07-31
K163049GOLNIT Non-Absorbable PTFE Surgical SutureAntarma Dba Golnit Sutures2017-06-21
K163639LS-5 ePTFE SutureLsi Solutions2017-06-02
K160744LOOK PTFE SutureSurgical Specialties Corporation2016-07-13
K140415MONOTEXRiverpoint Medical2014-03-26
K132464PTFE SURGICAL SUTUREOmnia Spa2014-02-12
K123811STITCHKITOrigami Surgical, LLC2013-09-05
K072076CYTOPLAST PTFE SUTUREOsteogenics Biomedical, Inc.2007-10-31

Legacy Summary#

summary

FDA Review#

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