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510(k) K042746

Device
PET-DOSE
Applicant
Comecer S.R.L.
510(k) number
K042746
Product code
KPT
Decision
Substantially Equivalent (SESE)
Decision date
2004-11-22
Date received
2004-10-04
Regulation
892.1360
Classification name
Calibrator, Dose, Radionuclide
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
Y

Applicant Contact#

Contact
E.J. Smith
Address
P.O. Box 4341 Crofton MD US 21114 21114

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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