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510(k) K791331

Device
THE TUCKER-SACH FOOT AND TUCKER-SYME FT
Applicant
Kiswood Manufacturing, Inc.
510(k) number
K791331
Product code
ISH
Decision
Substantially Equivalent (SESE)
Decision date
1979-08-03
Date received
1979-07-18
Regulation
890.3420
Classification name
Component, External, Limb, Ankle/Foot
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code ISH#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K051256SILVERSEAL ORTHOTIC COMPONENT WITH X-STATICNoble Fiber Technologies, Inc.2005-07-21
K823396FREE FLEX HEEL HEIGHT ADJUSTOROrthopedic Systems, Inc.1982-11-29
K820505ANKLE/FOOT EXTERNALMauch Laboratories, Inc.1982-03-08