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FDA 510(k) Application Details - K992227
Device Classification Name
System, Hemodialysis, Access Recirculation Monitoring
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510(K) Number
K992227
Device Name
System, Hemodialysis, Access Recirculation Monitoring
Applicant
IN-LINE DIAGNOSTICS CORP.
117 W. 200 S.
FARMINGTON, UT 84025 US
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Contact
MATTHEW L HAYNIE
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Regulation Number
876.5820
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Classification Product Code
MQS
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More FDA Info for this Product Code
Date Received
07/02/1999
Decision Date
07/30/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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