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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 K864140
Device Name KIDNEY PERFUSION MACHINE
Applicant
ADVANCED EQUIPMENT DEVELOPMENT, INC.
73 KERCHEVAL STE. 201
GROSSE PTE FARMS,  MI  48236
Applicant Contact WAYNE G WEGNER
Correspondent
ADVANCED EQUIPMENT DEVELOPMENT, INC.
73 KERCHEVAL STE. 201
GROSSE PTE FARMS,  MI  48236
Correspondent Contact WAYNE G WEGNER
Regulation Number876.5880
Classification Product Code
KDN  
Date Received10/21/1986
Decision Date 03/05/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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