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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Steam
510(k) Number K050263
Device Name MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU
Applicant
M.O. Com S.R.L.
Via Delle Azalee 1
Buccinasco (Mi),  IT 20090
Applicant Contact DANIELE TOSI
Correspondent
M.O. Com S.R.L.
Via Delle Azalee 1
Buccinasco (Mi),  IT 20090
Correspondent Contact DANIELE TOSI
Regulation Number880.6880
Classification Product Code
FLE  
Date Received02/04/2005
Decision Date 11/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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