FDA 510(k) Application Details - K953551

Device Classification Name System, Hemodialysis, Access Recirculation Monitoring

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510(K) Number K953551
Device Name System, Hemodialysis, Access Recirculation Monitoring
Applicant H&H CONTROL SYSTEMS
1200 HESTER LN.
JACKSON, MS 39209 US
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Contact ROBERT HESTER
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Regulation Number 876.5820

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Classification Product Code MQS
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Date Received 07/28/1995
Decision Date 06/21/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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