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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 K013855
Device Name MICROJET CRONO H
Applicant
CANE S.R.I.
P.O. BOX 7007
DEERFIELD,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
CANE S.R.I.
P.O. BOX 7007
DEERFIELD,  IL  60015
Correspondent Contact DANIEL KAMM
Regulation Number880.5725
Classification Product Code
FRN  
Date Received11/20/2001
Decision Date 05/09/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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