FDA 510(k) Application Details - K051256

Device Classification Name Component, External, Limb, Ankle/Foot

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510(K) Number K051256
Device Name Component, External, Limb, Ankle/Foot
Applicant NOBLE FIBER TECHNOLOGIES, INC.
421 SOUTH STATE ST.
CLARKS SUMMIT, PA 18411 US
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Contact WILLIAM F MCNALLY
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Regulation Number 890.3420

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Classification Product Code ISH
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Date Received 05/16/2005
Decision Date 07/21/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K051256


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