FDA.reportPublic FDA data

510(k) K791123

Device
EAR AND NOSE SPECULA
Applicant
XOMED, INC.
510(k) number
K791123
Product code
EPY  
Decision
Substantially Equivalent (SESE)
Decision date
1979-07-10
Date received
1979-06-15
Regulation
878.1800
Classification name
Speculum, Ent
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
1318 Lonedell Rd. Arnold MO US 63010 63010

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EPY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K950086PEDIA PALS, INCORPORATEDPedia Pals, Inc.1995-02-07
K925754ECONOMRudolf Riester GmbH & Co. KG1993-10-08
K853588FIBRELIGHT NASAL SPECULADowns Surgical , Ltd.1985-12-18
K834189JAKOBI SURG. INSTRUMENTS #7 44/47Imm Enterprises , Ltd.1984-03-06
K822370UNIVERSAL SPECULUM HOLDERTreace Medical, Inc.1982-09-09
K822373EAR SURGERY SPECULUMTreace Medical, Inc.1982-09-09
K822164EAR SPECULIKelleher Corp.1982-08-11
K780723OTOSCOPE SPECULAAbco Dealers, Inc.1978-05-09
K772370BARRAQUER OVAL SPECULUM-VARIOUS SIZESEdward Weck, Inc.1978-01-17
K772380FARRIOR OVAL SPECULUMEdward Weck, Inc.1978-01-17
K772385THIN-BLADED NASAL SPECULUMEdward Weck, Inc.1978-01-17

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