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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dialysate concentrate for hemodialysis (liquid or powder)
510(k) Number K150966
Device Name HMB32
Applicant
HAEMOPHARM BIOFLUIDS SRL
VIA DELL'INDUSTRIA 6
TOVO S. AGATA,  IT 23030
Applicant Contact GIUSEPPE TOMASINI
Correspondent
HEYER REGULATORY SOLUTIONS LLC
P.O. BOX 2151
AMHERST,  MA  01004
Correspondent Contact SHELIA HEMEON-HEYER
Regulation Number876.5820
Classification Product Code
KPO  
Date Received04/13/2015
Decision Date 12/04/2015
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
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