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F.P. Rubinstein Y Cia SRL - Dec. 17, 2015

Issue Date

Dec 17, 2015

Region

HQ

Category

Device
$117.00

F.P. Rubinstein Y Cia SRL

Contact Name

Federico P. Rubinstein

Contact Title

Director

Form483 Address 1

Calle David Luque 519

Form483 Address 2

Form483 City

Cordoba

Form483 State

Form483 Postal

X5004AKM

Form483 Country

Argentina

Inspection Range

Dec 14, 2015 - Dec 17, 2015

Pages

8

First Observation

An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Investigator(s): Marc S. Neubauer