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510(k) K141007

Device
DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE
Applicant
DEMETECH CORP.
510(k) number
K141007
Product code
GAQ  
Decision
Substantially Equivalent (SESE)
Decision date
2014-09-25
Date received
2014-04-18
Regulation
878.4495
Classification name
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
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
ANTHONY DIMERCURIO
Address
14175 NW 60th Ave. Miami Lakes FL US 33014 33014

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GAQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K203855CoNextions TR Tendon Repair SystemConextions Medical2022-04-22
K193209Wego-Stainless SteelFoosin Medical Supplies Inc., Ltd.2020-02-19
K172146MERISTEELM/s. Meril Endo Surgery Private Limited.2018-02-01
K170767Surgical Stainless Steel Suture, Stainless Steel SutureETHICON, Inc.2017-11-01
K140127FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMPPontis Orthopaedics, LLC2014-05-28
K081060FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5Core Essence Orthopaedics, LLC2008-12-24
K082828SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICESuturtek Incorporated2008-10-14
K063603SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17Suturtek Incorporated2007-02-07
K042606MODIFICATION TO:SYNTHES (USA) TITANIUM WIRESynthes (Usa)2005-05-27
K041333SYNTHES (USA) TITANIUM WIRESynthes (Usa)2004-08-27
K032468SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICESuturtek Incorporated2003-09-23
K023594TENO FIXOrtheon Medical, LLC2003-05-15
K030351STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLECp Medical2003-03-28
K023411STEELEX STERNUM SETAesculap, Inc.2002-12-19
K022777MANUAL TOUCHE SYSTEMOnux Medical, Inc.2002-11-19

Legacy Summary#

summary

FDA Review#

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