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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solution-Test Standard-Conductivity, Dialysis
510(k) Number K032075
Device Name CONDUCTIVITY STANDARD SOLUTION-METERCARE
Applicant
Ibp Instruments GmbH
Sutelstrasse 7a
Hannover,  DE D30659
Applicant Contact WERNER PFINGSTMANN
Correspondent
Tuv America, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Correspondent Contact STEFAN PREISS
Regulation Number876.5820
Classification Product Code
FKH  
Date Received07/07/2003
Decision Date 09/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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