FDA.reportPublic FDA data

510(k) K780375

Device
Pavlik Harness
Applicant
BIOMET, INC.
510(k) number
K780375
Product code
IOZ
Decision
Substantially Equivalent (SESE)
Decision date
1978-03-15
Date received
1978-03-08
Regulation
890.3665
Classification name
Splint, Abduction, Congenital Hip Dislocation
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 IOZ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K830243ABDUCTION PILLOWWarm & Form, Orthopedic Materials1983-03-08
K823820ABDUCTION PILLOWDanek Medical, Inc.1983-01-14
K810557HIP ABDUCTION SPLINTOrthomedics1981-03-13