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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K040456
Device Name FLEBOSET MULTIPLE
Applicant
Laboratorios Grifols, S.A.
C/Can Guasch, 2
Parets Del Valles, Barcelona,  ES 08150
Applicant Contact SEBASTIAN GASCON
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact SUSAN GILL
Regulation Number880.5440
Classification Product Code
LHI  
Date Received02/23/2004
Decision Date 03/09/2004
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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