FDA 510(k) Application Details - K043050

Device Classification Name

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510(K) Number K043050
Device Name HEMCON BANDAGE AND HEMCON BANDAGE OTC
Applicant HEMCON, INC.
10575 SW CASCADE BLVD.
SUITE 130
TIGARD, OR 97223 US
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Contact JOHN W MORGAN
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Regulation Number

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Classification Product Code QSY
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Date Received 11/04/2004
Decision Date 06/03/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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