FDA.reportPublic FDA data

510(k) K770476

Device
EXAM GOWN
Applicant
GENERAL MEDICAL CO.
510(k) number
K770476
Product code
FME  
Decision
Substantially Equivalent (SESE)
Decision date
1977-05-06
Date received
1977-03-11
Regulation
880.6265
Classification name
Gown, Examination
Medical specialty
General Hospital
Review panel
General Hospital
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 FME  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K880385KIMBERLY-CLARK PROFESSIONAL JACKETKimberly-Clark Corp.1988-02-19
K811915MONITOR/VITAL SIGNS TRAYAmerican Hospital Supply Corp.1981-07-28
K760954CROWNTEX EXAM. CAPE & GOWNGraham Manufacturing Co.1976-12-30
K760360SHIRT, MITTEN CUFF INFANTPrecept, Inc.1976-10-20

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