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510(k) K051256

Device
SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC
Applicant
Noble Fiber Technologies, Inc.
510(k) number
K051256
Product code
ISH
Decision
Substantially Equivalent (SESE)
Decision date
2005-07-21
Date received
2005-05-16
Regulation
890.3420
Classification name
Component, External, Limb, Ankle/Foot
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
WILLIAM F MCNALLY
Address
421 S. State St. Clarks Summit PA US 18411 18411

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ISH#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K823396FREE FLEX HEEL HEIGHT ADJUSTOROrthopedic Systems, Inc.1982-11-29
K820505ANKLE/FOOT EXTERNALMauch Laboratories, Inc.1982-03-08
K791331THE TUCKER-SACH FOOT AND TUCKER-SYME FTKiswood Manufacturing, Inc.1979-08-03