FDA 510(k) Application Details - K071557

Device Classification Name Dressing, Wound, Drug

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510(K) Number K071557
Device Name Dressing, Wound, Drug
Applicant COLLAMATRIX CO., INC.
NO. 360 RUIGUANG ROAD, 2ND FL.
NEIHU DISTRICT
TAIPEI 114 TW
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Contact DENNIS J.N. SEAH
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 06/07/2007
Decision Date 02/08/2008
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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