FDA.reportPublic FDA data

510(k) K830768

Device
DISPOSABLE SKIN STAPLER
Applicant
SURGEONS CHOICE, INC.
510(k) number
K830768
Product code
FZQ  
Decision
Substantially Equivalent (SESE)
Decision date
1983-04-12
Date received
1983-03-11
Regulation
878.4320
Classification name
Clip, Removable (skin)
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 FZQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K884783RANEY CLIPAlto Development Corp.1988-11-30
K873744LEUKOCLIP(R)Beiersdorf, Inc.1987-09-30
K830704ONE TIME DISPOSABLE SKIN STAPLERAcme United Corp.1983-04-12
K822963SURGICAL PRODUCTS, SKIN STAPLE REMOVERTemp-Stik Corp.1982-11-08
K822145COMPLETERichard-Allan Medical Ind., Inc.1982-10-22

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