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FDA 510(k) Application Details - K041080
Device Classification Name
General Surgery Tray
More FDA Info for this Device
510(K) Number
K041080
Device Name
General Surgery Tray
Applicant
D.I.R.R.A. S.R.L.
26, VIA GUIDO ROSSA
(Z.I. GERBOLINA)
VIADANA, MANTOVA I - 46019 IT
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Contact
ELISABETTA BACCHI
Other 510(k) Applications for this Contact
Regulation Number
878.4370
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Classification Product Code
LRO
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More FDA Info for this Product Code
Date Received
04/26/2004
Decision Date
11/30/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
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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