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510(k) K823820

Device
ABDUCTION PILLOW
Applicant
DANEK MEDICAL, INC.
510(k) number
K823820
Product code
IOZ  
Decision
Substantially Equivalent (SESE)
Decision date
1983-01-14
Date received
1982-12-17
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
K810557HIP ABDUCTION SPLINTOrthomedics1981-03-13
K780375PAVLIK HARNESSBiomet, Inc.1978-03-15

Legacy Summary#

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FDA Review#

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