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FDA 510(k) Application Details - K040283
Device Classification Name
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510(K) Number
K040283
Device Name
BIOPAD
Applicant
EURORESEARCH S.R.L.
1468 Harwell Avenue
Crofton, MD 21114 US
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Contact
E. SMITH
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Regulation Number
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Classification Product Code
QSY
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Date Received
02/06/2004
Decision Date
07/22/2005
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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