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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Perfusion, Kidney
510(k) Number K972066
Device Name BELZER-MPS
Applicant
Trans-Med Corp.
230 Evans Ave.
Elk River,  MN  55330
Applicant Contact SAMUEL C MCGHEE
Correspondent
Trans-Med Corp.
230 Evans Ave.
Elk River,  MN  55330
Correspondent Contact SAMUEL C MCGHEE
Regulation Number876.5880
Classification Product Code
KDN  
Date Received06/03/1997
Decision Date 11/26/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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