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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