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510(k) K862872

Device
FLEXIBLE VISUALIZATION CATHETER
Applicant
AMERICAN EDWARDS LABORATORIES
510(k) number
K862872
Product code
FEI  
Decision
Substantially Equivalent (SESE)
Decision date
1986-10-24
Date received
1986-07-30
Regulation
876.1500
Classification name
Instrument, Special Lens, For Endoscope
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
COLE, PH.D.
Address
P.O. Box 11150 17221 Red Hill Ave.(Irvine) Santa Ana CA US 92711 92711

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FEI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K873795M-LENS (THIRTY DEGREE ENDOSCOPE)Opto Vision, Inc.1988-01-14

Legacy Summary#

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FDA Review#

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