FDA.reportPublic FDA data

510(k) K812201

Device
PHOTOGRAPHIC EQUIPMENT
Applicant
REZNIK INSTRUMENTS
510(k) number
K812201
Product code
FEM  
Decision
Substantially Equivalent (SESE)
Decision date
1981-10-19
Date received
1981-08-04
Regulation
876.1500
Classification name
Accessories, Photographic, For Endoscope (exclude Light Sources)
Medical specialty
Gastroenterology/Urology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FEM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K940152CAMERA COVER WITH TEAR TIPHydro-Med Products, Inc.1994-10-28
K812542POLAROID INSTANT ENDOCAMERAPolaroid Corp.1981-10-19
K792512POLAROID LAND CAMERA FOR ENDOSCOPYPolaroid Corp.1979-12-20

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