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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K050726
Device Name SILVERSEAL SILVERAID 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
Classification Product Code
FRO  
Date Received03/18/2005
Decision Date 12/05/2005
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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