FDA.reportPublic FDA data

510(k) K851797

Device
53-100 TO 53-120 VARIOUS RECTAL SPECULA(SIMS, MATH
Applicant
ARTIBERIA
510(k) number
K851797
Product code
FFQ  
Decision
Substantially Equivalent (SESE)
Decision date
1985-05-23
Date received
1985-04-25
Regulation
876.4730
Classification name
Speculum, Rectal
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
GIL M SANCHEZ
Address
4518 Los Ranchitos San Antonio TX US 78233 78233

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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