FDA.reportPublic FDA data

510(k) K770529

Device
UNICET I
Applicant
Union Carbide Corp.
510(k) number
K770529
Product code
IPS
Decision
Substantially Equivalent (SESE)
Decision date
1977-04-05
Date received
1977-03-21
Regulation
890.3075
Classification name
Cane
Medical specialty
Physical Medicine
Review panel
Physical Medicine
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 IPS#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K832969WALKING CANEMaddak, Inc.1983-09-29
K832970CANE REACHERMaddak, Inc.1983-09-29
K821402LIGHT WEIGHT ALUMINUM CANESManuco Manufacturing Co., Inc.1982-04-21
K790558CERSA-CANEMaddak, Inc.1979-04-03
K790561OFFSET ALUMINUM CANEMaddak, Inc.1979-04-03
K790299FOREARM-CANEGuardian Products Co., Inc.1979-02-21
K780085CANE/REACHERFred Sammons, Inc.1978-01-30
K772267QUADRAPLEGIC WALKING AIDMed Fusion Systems, Inc.1977-12-20