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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Component, Cast
510(k) Number K043526
Device Name SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC
Applicant
Noble Fiber Technologies, Inc.
421 S. State St.
Clarks Summit,  PA  18411
Applicant Contact PATRICIA DAVIDSON
Correspondent
Noble Fiber Technologies, Inc.
421 S. State St.
Clarks Summit,  PA  18411
Correspondent Contact PATRICIA DAVIDSON
Regulation Number888.5940
Classification Product Code
LGF  
Date Received12/21/2004
Decision Date 03/10/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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