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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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