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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 K953551
Device Name KNOW-RECIRC
Applicant
H&H Control Systems
1200 Hester Ln.
Jackson,  MS  39209
Applicant Contact ROBERT HESTER
Correspondent
H&H Control Systems
1200 Hester Ln.
Jackson,  MS  39209
Correspondent Contact ROBERT HESTER
Regulation Number876.5820
Classification Product Code
MQS  
Date Received07/28/1995
Decision Date 06/21/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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