FDA.reportPublic FDA data

510(k) K003443

Device
SUCTION IRRIGATOR
Applicant
APPLIED MEDICAL
510(k) number
K003443
Product code
FHF  
Decision
Substantially Equivalent (SESE)
Decision date
2001-02-01
Date received
2000-11-06
Regulation
876.4370
Classification name
System, Evacuator, Fluid
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ANIL BHALANI
Address
22872 Avenida Empresa Rancho Santa CA US 92688 92688

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FHF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K093479DISPOSABLE SUCTION AND IRRIGATION SYSTEMModern Medical Equipment Mfg., Ltd.2010-05-19
K771986CATHETER, MEDIASTINAL&PERICARDIALThe Minnesota Back Brace Co.1977-10-28

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