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510(k) K812893

Device
SUPERFLAB
Applicant
MICK RADIO-NUCLEAR INSTRUMENTS, INC.
510(k) number
K812893
Product code
IYP  
Decision
Substantially Equivalent (SESE)
Decision date
1981-12-08
Date received
1981-10-15
Regulation
892.1370
Classification name
Phantom, Anthropomorphic, Nuclear
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IYP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K921878SCANMATE IIICircadian, Inc.1992-09-11
K844189LINEAR SCANNER PROBE ELSCINT LTD. TL-35Elscint, Inc.1985-02-25

Legacy Summary#

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FDA Review#

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