510(k) K903073

Device
LATEX FINGER COTS
Applicant
DONGKUK TRADING CO., LTD.
510(k) number
K903073
Product code
LZB  
Decision
Substantially Equivalent (SESE)
Decision date
1990-09-12
Date received
1990-07-12
Regulation
880.6250
Classification name
Finger Cot
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
H. S PARK
Address
K.P.O Box 150 Seoul, Korea KR

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LZB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K052387ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XXArthrex, Inc.2005-11-29
K992539PERCUGUARDDigit-Pro2000-02-18
K980827LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELINGTucker & Associates1998-05-04
K912042BETHEL PLUS MULTIPLE NAMESBethel Latex Products, Inc.1991-07-02

Legacy Summary#

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FDA Review#

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