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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 K020103
Device Name PRISMAFLO
Applicant
STIHLER ELECTRONIC GMBH
30 NORTHPORT RD.
SOUND BEACH,  NY  11789 -1734
Applicant Contact RICHARD C LANZILLOTO
Correspondent
STIHLER ELECTRONIC GMBH
30 NORTHPORT RD.
SOUND BEACH,  NY  11789 -1734
Correspondent Contact RICHARD C LANZILLOTO
Regulation Number876.5820
Classification Product Code
KOC  
Subsequent Product Code
LGZ  
Date Received01/11/2002
Decision Date 07/24/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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