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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Component, External, Limb, Ankle/Foot
510(k) Number K051256
Device Name SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC
Applicant
Noble Fiber Technologies, Inc.
421 S. State St.
Clarks Summit,  PA  18411
Applicant Contact WILLIAM F MCNALLY
Correspondent
Noble Fiber Technologies, Inc.
421 S. State St.
Clarks Summit,  PA  18411
Correspondent Contact WILLIAM F MCNALLY
Regulation Number890.3420
Classification Product Code
ISH  
Date Received05/16/2005
Decision Date 07/21/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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