FDA.reportPublic FDA data

510(k) K932128

Device
CMI E-Z FLO BULB P.N. 701
Applicant
COLUMBIA MEDICAL & SURGICAL, INC.
510(k) number
K932128
Product code
FFY  
Decision
Substantially Equivalent (SESE)
Decision date
1994-04-07
Date received
1993-05-03
Regulation
876.1500
Classification name
Adaptor, Bulbs, Miscellaneous, For Endoscope
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
BEVERLEE LOUVRING
Address
P.O. Box 5877 Bend OR US 97708 97708

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FFY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K900781WORKING CHANNEL VALVEApplied Urology, Inc.1990-04-25

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases