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FDA 510(k) Application Details - K050263
Device Classification Name
Sterilizer, Steam
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510(K) Number
K050263
Device Name
Sterilizer, Steam
Applicant
M.O.C.O.M. SRL
VIA DELLE AZALEE 1
BUCCINASCO (MI) 20090 IT
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Contact
DANIELE TOSI
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Regulation Number
880.6880
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Classification Product Code
FLE
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Date Received
02/04/2005
Decision Date
11/21/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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