510(k) K780229

Device
Abdominal Belt
Applicant
BIOMET, INC.
510(k) number
K780229
Product code
KTD
Decision
Substantially Equivalent (SESE)
Decision date
1978-03-02
Date received
1978-02-09
Regulation
890.3490
Classification name
Orthosis, Abdominal
Medical specialty
Physical Medicine
Review panel
Physical Medicine
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 KTD#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K823663ABDOMINAL BINDERWarm & Form, Orthopedic Materials1982-12-30
K823164ABDOMINAL BINDERWarm & Form, Orthopedic Materials1982-11-16