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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 K050339
Device Name SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE
Applicant
Laboratorios Grifols, S.A.
C/Can Guasch, 2
Parets Del Valles, Barcelona,  ES 08150
Applicant Contact SEBASTIAN GASCON
Correspondent
Underwriters Laboratories, Inc.
1655 Scott Blvd.
Santa Clara,  CA  95050
Correspondent Contact MORTEN S CHRISTENSEN
Regulation Number880.5440
Classification Product Code
LHI  
Date Received02/11/2005
Decision Date 02/25/2005
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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