FDA 510(k) Application Details - K061474

Device Classification Name Dressing, Wound, Collagen

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510(K) Number K061474
Device Name Dressing, Wound, Collagen
Applicant COLLAMATRIX CO., INC.
2ND FLOOR, NO. 360, RUIGUANG
RD 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 KGN
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Date Received 05/30/2006
Decision Date 07/05/2006
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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