FDA.reportPublic FDA data

510(k) K904800

Device
Sif-sw
Applicant
OLYMPUS CORP.
510(k) number
K904800
Product code
FDA
Decision
Substantially Equivalent (SESE)
Decision date
1991-03-27
Date received
1990-10-24
Regulation
876.1500
Classification name
Enteroscope And Accessories
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DANIEL J DILLON
Address
4 Nevada Dr. Lake Success NY US 11042 11042

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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