FDA.reportPublic FDA data

510(k) K821127

Device
KEY DRILL
Applicant
KEY MEDICAL, INC.
510(k) number
K821127
Product code
GFG  
Decision
Substantially Equivalent (SESE)
Decision date
1982-06-03
Date received
1982-04-20
Regulation
878.4820
Classification name
Bit, Surgical
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
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 GFG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K935225MITEK MODULAR DRILL BITMitek Surgical Products, Inc.1994-04-07
K821486MICRO DRILLSSpire Medical, Inc.1982-06-09

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