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510(k) K812819

Device
ETHICON* SURGICAL SUTURES W/COMPRESS BOL
Applicant
ETHICON, INC.
510(k) number
K812819
Product code
KGS  
Decision
Substantially Equivalent (SESE)
Decision date
1981-11-20
Date received
1981-10-07
Regulation
878.4930
Classification name
Retention Device, Suture
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KGS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K030031SOFT TISSUE ANCHORING WASHERSAccu-Speed, Incorporated2003-01-28
K020480RBMSmith & Nephew, Inc.2002-03-12
K964935SUTURE LOCKSmith & Nephew Endoscopy, Inc.1997-02-25
K941740ACUFEX ROTATOR CUFF FIXATION BUTTONAcufex Microsurgical, Inc.1995-06-30
K930675MITEK CONE WASHERMitek Surgical Products, Inc.1993-11-09
K904435VENTROFIL TENSION RELIEF SUTURE SETAesculap, Inc.1991-08-29
K911225TRAY DOUGHThe Hygenic Corp.1991-04-17
K904136SUTURE TENSION ADJUSTMENT REELSurgical Systems, Inc.1990-10-02
K902001SURGICAL RETENTION BARAcufex Microsurgical, Inc.1990-05-09
K896310ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGEAcufex Microsurgical, Inc.1989-11-20
K893995DERMACARE TIE HOLDERDermacare1989-08-11
K884565ACUFEX FIXATION BUTTONAcufex Microsurgical, Inc.1989-02-27
K883299SUTURE RETENTION DEVICEEdwards Orthopaedics Div., Baxter Healthcare Corp.1988-08-23
K872608HEWSON A.C.L. GUIDE SETConcept, Inc.1987-09-16
K863570LE VEEN WOUND SPLINTTek-Aid, Inc.1986-09-29

Legacy Summary#

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FDA Review#

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