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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, Elastomeric
510(k) Number K040752
Device Name DOSI-FUSER
Applicant
Leventon, S.A.
C/Newton 18-24, Poligono
Industrial Sesrovires, Sant
Esteve Sesrovires, Barcelona,  ES 08635
Applicant Contact JOAQUIM SORIANO
Correspondent
Tuv America, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Correspondent Contact STEFAN PRISS
Regulation Number880.5725
Classification Product Code
MEB  
Date Received03/24/2004
Decision Date 04/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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