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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, hemodialysis, implanted
510(k) Number K023847
Device Name HEMO-STREAM HEMODIALYSIS CATHETER SET
Applicant
REX MEDICAL
55 Northern Blvd.
Suite 200
Great Neck,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
REX MEDICAL
55 Northern Blvd.
Suite 200
Great Neck,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number876.5540
Classification Product Code
MSD  
Date Received11/19/2002
Decision Date 04/30/2003
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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