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510(k) K881591

Device
A2J MZ 45 LASER LIGHT FOR POSITIONING
Applicant
A2J, INC.
510(k) number
K881591
Product code
IWX  
Decision
Substantially Equivalent (SESE)
Decision date
1988-04-27
Date received
1988-04-13
Regulation
892.6500
Classification name
Barrier, Control Panel, X-ray, Movable
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ZIMMER
Address
10500 Richmond Suite 201 Houston TX US 77042 77042

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IWX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K850813MOBILE LEAD PLASTIC X-RAY BARRIERSVictoreen, Inc.1985-04-10
K781068AUTOMATIC FILM PROCESSORIO M. R80Tecnomed, Inc.1978-07-17

Legacy Summary#

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FDA Review#

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