FDA 510(k) Application Details - K063190

Device Classification Name

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510(K) Number K063190
Device Name SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC
Applicant NOBLE FIBER TECHNOLOGIES, INC.
300 PALM ST.
SCRANTON, PA 18505 US
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Contact PATRICIA DAVIDSON
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Regulation Number

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Classification Product Code QSY
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Date Received 10/20/2006
Decision Date 08/21/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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