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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name accessories, blood circuit, hemodialysis
510(k) Number K082758
Device Name PRISMAFLO II
Applicant
STIHLER ELECTRONIC GMBH
30 NORTHPORT RD.
SOUND BEACH,  NY  11789 -1734
Applicant Contact STEPHEN T MLCOCH
Correspondent
STIHLER ELECTRONIC GMBH
30 NORTHPORT RD.
SOUND BEACH,  NY  11789 -1734
Correspondent Contact STEPHEN T MLCOCH
Regulation Number876.5820
Classification Product Code
KOC  
Date Received09/19/2008
Decision Date 12/19/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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