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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 K033900
Device Name X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSING
Applicant
Noble Fiber Technologies
421 S. State St.
Clarks Summit,  PA  18411
Applicant Contact PATRICIA DAVIDSON
Correspondent
Noble Fiber Technologies
421 S. State St.
Clarks Summit,  PA  18411
Correspondent Contact PATRICIA DAVIDSON
Classification Product Code
FRO  
Date Received12/17/2003
Decision Date 01/14/2005
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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