FDA.reportPublic FDA data

510(k) K853119

Device
URODYN 1000
Applicant
DANTEC ELECTRONICS, INC.
510(k) number
K853119
Product code
FFO  
Decision
Substantially Equivalent (SESE)
Decision date
1985-10-04
Date received
1985-07-25
Regulation
876.4730
Classification name
Retractor, Self-retaining
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
OLE STRANGE
Address
6 Pearl Ct. Allendale NJ US 07401 07401

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FFO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K993544SPACE-OR RETRACTORAdvanced Surgical Concepts (Asc)1999-12-22
K870897KODNER ANAL PERIONEAL RETRACTORSur-Med Instruments, Inc.1987-06-04
K860368URDYN 5000 (UROFLOWMETER)Dantec Electronics, Inc.1986-04-23
K852083THE KENDALL URINARY OUTPUT MONITORThe Kendal Co.1985-09-20

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