FDA 510(k) Application Details - K071519

Device Classification Name

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510(K) Number K071519
Device Name HEMCON CHITOFLEX-SURGICAL DRESSING
Applicant HEMCON, INC.
10575 SW CASCADE AVENUE
SUITE 130
PORTLAND, OR 97223-4363 US
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Contact KEVIN HAWKINS
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Regulation Number

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Classification Product Code QSY
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Date Received 06/04/2007
Decision Date 08/06/2007
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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