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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, I.V.
510(k) Number K031419
Device Name GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML
Applicant
LABORATORIOS GRIFOLS, S.A.
POL. LEVANTE C/CAN GUASCH, 2
PARETS DEL VALLES, BARCELONA,  ES 08150
Applicant Contact SEBASTIAN GASCON
Correspondent
UNDERWRITERS LABORATORIES, INC.
12 LABORATORY DR.
RESEARCH TRIANGLE,  NC  27709
Correspondent Contact PAMELA GWYNN
Regulation Number880.5025
Classification Product Code
KPE  
Subsequent Product Codes
FPB   NEP  
Date Received05/05/2003
Decision Date 11/24/2003
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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