FDA.reportPublic FDA data

510(k) K833602

Device
ROLLER KNIFE-TRANSVERSE -SAGITTAL
Applicant
MICROTEK MEDICAL, INC.
510(k) number
K833602
Product code
JYO  
Decision
Substantially Equivalent (SESE)
Decision date
1984-01-03
Date received
1983-10-12
Regulation
874.4420
Classification name
Knife, Ear
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 JYO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K910212COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYSTAcoustic Imaging Technologies Corp.1991-07-11
K841006EAR KNIFE-VARIOUSPremier Dental Products Co.1984-05-30
K840764EAR KNIVESSharpoint, Inc.1984-05-21
K823911KNIFE BLADE TIPTreace Medical, Inc.1983-01-21
K772372ROLLER KNIFEEdward Weck, Inc.1978-01-17
K772384MYRINGOTOMY KNIFEEdward 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