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510(k) K832441

Device
SUTURE-AID BOOTIES
Applicant
OMEGA-MED INTL., INC.
510(k) number
K832441
Product code
KDC  
Decision
Substantially Equivalent (SESE)
Decision date
1984-03-05
Date received
1983-07-25
Regulation
878.4800
Classification name
Instrument, Surgical, Disposable
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 KDC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K943229DISPOSABLE SURGICAL SCISSORS AND FORCEPSY.M.K. International Co., Ltd.1994-08-19
K936226SURGIMED BREAST LOCALIZATION NEEDLE WIRE SETMeadox Medicals, Div. Boston Scientific Corp.1994-03-07
K920153THERMUFF BAGTechstyles1992-07-01
K920263MANUAL SURGICAL INSTRUMENTSPhoenix Instruments Div.1992-05-06
K915064DISPOSABLE CAUTERY ABRASIVE PADAmerican Medical Mfg., Inc.1992-03-11
K914960INSTRUMENT ORGANIZERO.R. Concepts, Inc.1992-02-28
K912834SHUR-GRIPInman Medical Corp.1991-07-26
K910079DISPOSABLE INTRODUCER SHEATHApplied Vascular Devices, Inc.1991-02-27
K905240VESSELOOPSSparta Surgical Corp.1991-02-06
K903649BRADLEY TENACULUM HOLDERMarlo Surgical Technology1990-11-02
K900566RICHARD-ALLAN VESSEL LOOPSRichard-Allan Medical Ind., Inc.1990-05-03
K896676KEY VASCULAR LOOPSKey Surgical, Inc.1990-02-27
K854890HOOK PROBEEuro-Med Intl.1986-05-02
K854894SPOONEuro-Med Intl.1986-05-02
K854895BASKET FORCEPEuro-Med Intl.1986-05-02

Legacy Summary#

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FDA Review#

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