FDA.reportPublic FDA data

510(k) K760951

Device
DEVON COOL FACE
Applicant
Devon Industries, Inc.
510(k) number
K760951
Product code
KYR
Decision
Substantially Equivalent (SESE)
Decision date
1976-12-30
Date received
1976-11-01
Regulation
880.6050
Classification name
Bag, Ice
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Third party reviewed
N

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 KYR#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K833872SAV-A-LIMBSil-Med Corp.1984-02-04
K810653VINYL ICE BAGFirst Industries, Inc.1981-03-27
K780608ICE BAG, VINYLAbco Dealers, Inc.1978-06-06