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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 K993587
Device Name HP M2376A DEVICE LINK SYSTEM
Applicant
HEWLETT-PACKARD CO.
3000 MINUTEMAN RD.
ANDOVER,  MA  01810 -1085
Applicant Contact MIKE HUDON
Correspondent
HEWLETT-PACKARD CO.
3000 MINUTEMAN RD.
ANDOVER,  MA  01810 -1085
Correspondent Contact MIKE HUDON
Regulation Number876.5820
Classification Product Code
MQS  
Date Received10/22/1999
Decision Date 01/20/2000
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
Predetermined Change
Control Plan Authorized		 No
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