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510(k) K883527

Device
GRID/RADIOGRAPHIC
Applicant
UMI, INC.
510(k) number
K883527
Product code
IXJ  
Decision
Substantially Equivalent (SESE)
Decision date
1988-09-02
Date received
1988-08-18
Regulation
892.1910
Classification name
Grid, Radiographic
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MARIA BONASTIA
Address
2190 S. Mason Rd., Suite 304 St. Louis MO US 63131 63131

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IXJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K964025MITAYA ALUMINUM INTERSPACED X-RAY GRIDX-Ray Accessory Corp.1997-06-13
K963893FIBRE INTERSPACED X-RAY GRIDSmit Rontgen1996-11-07
K962338RADIOGRAPHIC GRIDUnidex Group, Inc.1996-07-03
K954294HIGH TRANSMISSION CELLULAR (HTC) GRIDS 18X24 CM & 24X30 CM SIZESThermotrex Corp.1996-02-02
K945697SK S-RAY GRIDSSeibu Techno Coproration1995-01-31
K945327JPI X-RAY GRIDJpi America, Inc.1995-01-20
K941626GRIDGILGilardoni S.P.A.1994-05-13
K940309X-RAY GRID (RADIOLOGICAL GRID)J.P.I. Chicago Co.1994-04-22
K926445SOYEE ALUMINUM INTERSPACED X-RAY GRIDX-Ray Accessories Mfg. Co.1993-04-07
K926261JPI ALUMINUM INTERSPACED X-RAY GRIDJpi, Inc.1993-03-18
K925997KODAK EKTASCAN SP CASSETTEEastman Kodak Company1992-12-17
K901012RADIOGRAPHIC GRIDInfab Corp.1990-03-28
K854459TBX MEDICAL X-RAY TABLEGendex Corp.1986-02-12
K837776AOR X-RAY ALIGMENT PADZimmer, Inc.1983-08-18

Legacy Summary#

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FDA Review#

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