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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, hemodialysis, access recirculation monitoring
510(k) Number K960817
Device Name HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2)
Applicant
TRANSONIC SYSTEMS, INC.
34 DUTCH MILL RD.
ITHACA,  NY  14850
Applicant Contact CORNELIS J DROST
Correspondent
TRANSONIC SYSTEMS, INC.
34 DUTCH MILL RD.
ITHACA,  NY  14850
Correspondent Contact CORNELIS J DROST
Regulation Number876.5820
Classification Product Code
MQS  
Date Received02/28/1996
Decision Date 02/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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