FDA.reportPublic FDA data

510(k) K864835

Device
TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR*
Applicant
EISAI U.S.A., INC.
510(k) number
K864835
Product code
FCD  
Decision
Substantially Equivalent (SESE)
Decision date
1987-02-11
Date received
1986-12-09
Regulation
876.5210
Classification name
Barium Enema Kit
Medical specialty
Gastroenterology/Urology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MINORU ABE
Address
20908 Higgins Ct. Torrance CA US 90501 90501

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FCD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K934585PRO-FLO SYSTEM WITH INFRA-RED REMOTE CONTROLLafayette Pharmaceuticals, Inc.1993-11-03

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