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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 K162216
Device Name GRI-FILL PERISTALTIC SET
Applicant
Laboratorios Grifols, S.A.
C/Can Guasch, 2
Parets Del Valles,,  ES 08150
Applicant Contact MARTA DANIELA SERRA DE FORTUNY
Correspondent
Laboratorios Grifols, S.A.
C/Can Guasch, 2
Parets Del Valles,,  ES 08150
Correspondent Contact MARTA DANIELA SERRA DE FORTUNY
Regulation Number880.5440
Classification Product Code
LHI  
Date Received08/08/2016
Decision Date 10/19/2017
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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