FDA.reportPublic FDA data

510(k) K801589

Device
AUTO SUTURE DISP. 30, ETC. & SURG. STAP
Applicant
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
510(k) number
K801589
Product code
FHM  
Decision
Substantially Equivalent (SESE)
Decision date
1980-08-04
Date received
1980-07-11
Regulation
878.4800
Classification name
Apparatus, Suturing, Stomach And Intestinal
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 FHM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K801590AUTO SUTURE DISPOSABLE GIA SURG. STAPLERUnited States Surgical, A Division of Tyco Healthc1980-08-04

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