FDA 510(k) Application Details - K041013

Device Classification Name Dressing, Wound, Drug

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510(K) Number K041013
Device Name Dressing, Wound, Drug
Applicant HEDONIST BIOCHEMICAL TECHNOLOGIES CO., LTD.
6F, NO. 208, RUEI-GUANG ROAD
TAIPEI 114 TW
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Contact ERIC LUO, PH.D.
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 04/20/2004
Decision Date 07/07/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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