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510(k) K895799

Device
RECTILINEAR SCANNER MODEL #187-270
Applicant
ATOMIC PRODUCTS CORP.
510(k) number
K895799
Product code
IYW  
Decision
Substantially Equivalent (SESE)
Decision date
1990-02-01
Date received
1989-09-28
Regulation
892.1300
Classification name
Scanner, Rectilinear, Nuclear
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CLYDE SCHLEIN
Address
P.O. Drawer R Shirley NY US 11967 11967

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IYW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K944684POLYSCAN DIGITAL SCANNERMse Medizintechnik GmbH & Co. KG1995-05-15
K882453POLYSCAN DIGITAL SCANNERMedical and Scientific Enterprises, Inc.1988-11-23
K780395IMAGER, BODY SECTION, RADIONUCLIDEUnion Carbide Corp.1978-03-31

Legacy Summary#

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FDA Review#

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