FDA 510(k) Application Details - K031684

Device Classification Name

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510(K) Number K031684
Device Name TOPKIN WOUND DRESSING
Applicant BIOMET MERCK GMBH
ATLES WIDALMI 12
RIED BEI KERZERS 3216 CH
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Contact THOMAS KIEWITT
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Regulation Number

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Classification Product Code QSZ
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Date Received 05/30/2003
Decision Date 10/30/2003
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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