FDA.reportPublic FDA data

510(k) K860622

Device
STUDEX EAR PIERCING GUNS
Applicant
ONYX INDUSTRIES, INC.
510(k) number
K860622
Product code
JYS  
Decision
Substantially Equivalent (SESE)
Decision date
1986-10-17
Date received
1986-02-19
Regulation
874.4420
Classification name
Perforator, Ear-lobe
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DANA MALTUN
Address
25311 S. Normandie Ave. Harbor City CA US 90710 90710

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JYS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K860678J.K. TEMPLETON EAR PIERCING GUNS/INSTRUMENTS/STUDSJay Kenny Templeton1986-08-29
K772171EAR PIERCING DEVICERobert C. Cameron1978-01-03

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