FDA 510(k) Application Details - K033587

Device Classification Name Dressing, Wound, Drug

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510(K) Number K033587
Device Name Dressing, Wound, Drug
Applicant NOBLE FIBER TECHNOLOGIES
421 S. STATE ST.
CLARKS SUMMIT, PA 18411 US
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Contact PATRICIA DAVIDSON
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 11/13/2003
Decision Date 08/05/2004
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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