FDA.reportPublic FDA data

510(k) K913168

Device
SALIBAG
Applicant
NIX CO. LTD.
510(k) number
K913168
Product code
EGZ  
Decision
Substantially Equivalent (SESE)
Decision date
1991-09-06
Date received
1991-07-17
Regulation
872.1905
Classification name
Holder, Film, X-ray
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
PATRICIA CHRISTIAN
Address
C/O Meadox Consulting Services 112 Bauer Dr. Oakland NJ US 07436 07436

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EGZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K913160ID-TABNix Co. , Ltd.1991-09-06
K890355DENTAL X-RAY BITE BLOCKBite-A-Block1989-06-12
K853451TROLL-BITETrollplast, Inc.1986-01-21
K852170EZX YELLOW, BLUE OR ORANGEStrong Marketing1985-09-05
K853005S.S. WHITE DENTAL X-RAY FILM HOLDER & ALIGNING ARMThe S. S. White Co.1985-08-13
K813378UNI-BITE DENTAL X-RAY FILM HOLDERRinn Corp.1982-01-29
K801079KWIX-BITE X-RAY FILM HOLDERHenry Schein, Inc.1980-05-20

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