FDA 510(k) Application Details - K111163

Device Classification Name

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510(K) Number K111163
Device Name CHITOGAUZE FUSION
Applicant HEMCON MEDICAL TECHNOLOGIES, INC.
10575 SW CASCADE AVENUE
SUITE 130
PORTLAND, OR 97223-4363 US
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Contact KENDRA RATHKEY
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Regulation Number

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Classification Product Code QSY
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Date Received 04/26/2011
Decision Date 05/17/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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