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510(k) K852160

Device
RADIOLOGICAL MARKING PEN
Applicant
TRUETT LABORATORIES, INC.
510(k) number
K852160
Product code
JAC  
Decision
Substantially Equivalent (SESE)
Decision date
1985-07-18
Date received
1985-02-28
Regulation
892.1640
Classification name
System, X-ray, Film Marking, Radiographic
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
NEAL GOODWIN
Address
798 N. Coney Ave. Azusa CA US 91702 91702

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JAC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K942883DIGITAL I.D. CAMERAMiles Inc., Agfa Division1994-09-30
K930752CT/MRI TOPOGRAPHIC MARKERI.Z.I. Corp.1993-11-19
K932357FUJI EC ID CAMERAFujifilm Medical System U.S.A., Inc.1993-07-26
K925892SOLSTICE XRAY RING MARKER PADSolstice Corp.1993-05-18
K926404KODAK X-OMATIC IDENTIFICATION CAMERA, MODEL 4 & 4LEastman Kodak Company1993-03-04
K923533ADMARKPlanmeca USA, Inc.1993-03-04
K925332BENNETT X-RAY ID PLUSBennett X-Ray Technologies1992-11-27
K924345RADIOGRAPHIC FILM MARKETING SYSTEMFischer Imaging Corp.1992-11-27
K920031KODAK X-OMATIC IDENT. CAMERA MAMMOGRAPHY UPGRADEEastman Kodak Company1992-02-12
K915088KODAK MIN-R IDENTIFICATION CAMERAEastman Kodak Company1991-12-02
K913478RADIOGRAPHIC FILM MARKING SYSTEMLorad Medical Systems, Inc.1991-10-15
K911873X-MARXMacbrud Corp. Medical Div.1991-07-19
K910354DU PONT IDENTIFICATION CAMERADupont Medical Products1991-03-29
K890467KODAK PORTABLE IDENTIFICATION CAMERAEastman Kodak Company1989-02-16
K882519X-RAY MARKERKarlin Technology, Inc.1988-08-09

Legacy Summary#

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FDA Review#

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