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510(k) K820505

Device
ANKLE/FOOT EXTERNAL
Applicant
MAUCH LABORATORIES, INC.
510(k) number
K820505
Product code
ISH  
Decision
Substantially Equivalent (SESE)
Decision date
1982-03-08
Date received
1982-02-25
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
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 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
K791331THE TUCKER-SACH FOOT AND TUCKER-SYME FTKiswood Manufacturing, Inc.1979-08-03

Legacy Summary#

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FDA Review#

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