FDA 510(k) Application Details - K091719

Device Classification Name Dressing, Wound, Drug

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510(K) Number K091719
Device Name Dressing, Wound, Drug
Applicant QUINNOVA PHARMACEUTICALS
411 S. STATE ST. 3RD. FLOOR
NEWTOWN, PA 18940 US
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Contact SHAHBAZ KHAN
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 06/11/2009
Decision Date 07/30/2009
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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