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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name meter, conductivity, non-remote
510(k) Number K020908
Device Name HDM97
Applicant
IBP INSTRUMENTS GMBH
SUTELSTR. 7A
HANNOVER,  DE 30659
Applicant Contact WERNER PFINGSTMANN
Correspondent
TUV AMERICA, INC.
1775 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact MARK JOB
Regulation Number876.5820
Classification Product Code
FIZ  
Date Received03/20/2002
Decision Date 05/22/2002
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
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