FDA.reportPublic FDA data

510(k) K781557

Device
24-HOUR URINE COLLECTION COOLING WRAP
Applicant
SAGE PRODUCTS, INC.
510(k) number
K781557
Product code
FMH  
Decision
Substantially Equivalent (SESE)
Decision date
1978-10-17
Date received
1978-09-11
Regulation
864.3250
Classification name
Container, Specimen, Sterile
Medical specialty
Pathology
Review panel
General Hospital
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 FMH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K900983TRI-TECH URINE SPECIMEN KITTri-Tech, Inc.1990-09-17
K823763VARIOUS-SPECIMEN COLLECTORSCordis Corp.1983-01-19
K820180CALCULI FILTER CUPOmnimedical1982-02-05
K812933LANCER SPECIMEN CONTAINERSherwood Medical Co.1981-11-06
K802340SPECIMEN SETAmerican Pharmaseal Div. Ahsc1980-10-10
K802002URINE SPECIMEN CONTAINER #'S 1013-1016Pollak (Intl.), Ltd.1980-09-09
K800947MIDSTREAM COLLECTION KITSage Products, Inc.1980-05-30
K800233ABCO MIDSTREAM URINE COLLECTION SETAbco Dealers, Inc.1980-02-26
K800309SPECIMEN COLLECTION PANSage Products, Inc.1980-02-26
K792710PARA-PAK CLEAN VIALMeridian Diagnostics, Inc.1980-01-28
K792156LANCER SPECIMEN CONTAINERSherwood Medical Co.1979-12-10
K792211SPECIMAN CUP & EMESIS BASINGeneral Clinical Plastics Corp.1979-11-16
K790915JUHN TYM-TAPXomed, Inc.1979-06-27
K790291OPERATING ROOM SPECIMEN CONTAINERSage Products, Inc.1979-04-10
K780057URINE SAMPLE COLLECTION KITC.R. Bard, Inc.1978-02-21

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