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510(k) K885018

Device
ABSORBABLE SURGICAL GUT SUTURE*
Applicant
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
510(k) number
K885018
Product code
GAL  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1989-08-22
Date received
1988-12-05
Regulation
878.4830
Classification name
Suture, Absorbable, Natural
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
S HENNIG
Address
150 Glover Ave. Norwalk CT US 06856 06856

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GAL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K142656Surgical Gut SutureCovidien2015-01-29
K072930DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUTDemetech Corp.2008-04-30
K042287UNIPLAIN & UNICHROMUnited Medical Industries Co. , Ltd.2005-09-07
K042897AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGEEthicon Endo-Surgery, Inc.2004-11-19
K030227SUTURTEK FASTCLOSE SUTURING DEVICESuturtek Incorporated2003-03-17
K020597SERRALGUTSerral, S.A. DE C.V.2002-08-14
K021043GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMICGramsmed, LLC2002-06-21
K011105SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICEQrc Consulting2001-05-30
K001299PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USPCp Medical2000-06-23
K000542PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USPArc Medical Supplies (Beijing) Co, Ltd.2000-04-28
K993695LIGA-LOOP SUTURE APPLICATORHysterx, Inc.2000-04-13
K994002PLAIN/CHROMIC CATGUTTrading Consultants and Distributors Intl., Inc.2000-02-04
K982646AILEE SUTURES AND AILEE NEEDLESMyco Medical Supplies, Inc.1999-06-02
K991223ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONICAesculap, Inc.1999-04-30
K961931PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USPR. K. Medical L. L. C.1996-07-29

Legacy Summary#

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FDA Review#

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