FDA 510(k) Application Details - K023298

Device Classification Name

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510(K) Number K023298
Device Name HEMCON BANDAGE
Applicant HEMCON, INC.
10575 SW CASCADE AVE.
SUITE 130
TIGARD, OR 97223 US
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Contact JAMES F HENSEL
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Regulation Number

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Classification Product Code QSY
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Date Received 10/03/2002
Decision Date 11/04/2002
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 Y



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