FDA.reportPublic FDA data

510(k) K822183

Device
MOUTH GAGS
Applicant
KELLEHER CORP.
510(k) number
K822183
Product code
KBN  
Decision
Substantially Equivalent (SESE)
Decision date
1982-08-16
Date received
1982-07-23
Regulation
874.4420
Classification name
Gag, Mouth
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
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 KBN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K834540OP-CON SURGICAL INSTRUMENT #9Imm Enterprises , Ltd.1984-03-06
K780992MILLARD MOUTH GAGNestor Engineering Associates, Inc.1978-08-17

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