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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Pump, Infusion
510(k) Number K091042
Device Name CRONO S-PID 50
Applicant
Cane S.R.L.
Via Pavia, 105/I 10090
Rivoli-Cascine Vica (Torino),  IT
Applicant Contact CARLO MUSSO
Correspondent
Cane S.R.L.
Via Pavia, 105/I 10090
Rivoli-Cascine Vica (Torino),  IT
Correspondent Contact CARLO MUSSO
Regulation Number880.5725
Classification Product Code
FRN  
Date Received04/13/2009
Decision Date 05/12/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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