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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K041495
Device Name PENTADEFLUE IV SOLUTION ADMINISTRATION SETS
Applicant
Pentaferte S.P.A
Loc. Nocella Statale 262
Campli (Teramo),  IT 64012
Applicant Contact VITTORIO SERVIDORI
Correspondent
Pentaferte S.P.A
Loc. Nocella Statale 262
Campli (Teramo),  IT 64012
Correspondent Contact VITTORIO SERVIDORI
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/04/2004
Decision Date 04/15/2005
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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