FDA.reportPublic FDA data

510(k) K910914

Device
SURGICAL TISSUE POUCH
Applicant
COOK UROLOGICAL, INC.
510(k) number
K910914
Product code
KGY  
Decision
Substantially Equivalent (SESE)
Decision date
1991-03-28
Date received
1991-03-05
Regulation
878.4100
Classification name
Bag, Intestine
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MICHELLE YOUNG
Address
1100 W. Morgan St. P.O. Box 227 Spencer IN US 47460 47460

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KGY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K933085GOODMAN BANDAGEMegadyne Medical Products, Inc.1993-12-23
K913678TROCAR CATHETERMedovations, Inc.1991-12-16
K832318ISOLATION BAG 3M3M Company1983-10-31
K801823BAND-AID BRAND TRICOT MESH BANDAGESJohnson & Johnson Professionals, Inc.1980-08-20
K801824BAND-AID BRAND FLEXIBLE FABRIC BANDAGEJohnson & Johnson Professionals, Inc.1980-08-20

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