FDA 510(k) Application Details - K093155

Device Classification Name Dressing, Wound, Drug

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510(K) Number K093155
Device Name Dressing, Wound, Drug
Applicant PURICORE INC.
508 LAPP RD.
MALVERN, PA 19355 US
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Contact DENNIS MAHONEY
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 10/06/2009
Decision Date 03/01/2010
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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