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510(k) K823164

Device
ABDOMINAL BINDER
Applicant
WARM & FORM, ORTHOPEDIC MATERIALS
510(k) number
K823164
Product code
KTD  
Decision
Substantially Equivalent (SESE)
Decision date
1982-11-16
Date received
1982-10-25
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
K780229ABDOMINAL BELTBiomet, Inc.1978-03-02

Legacy Summary#

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FDA Review#

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