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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 K071422
Device Name 15.5F 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 Received05/22/2007
Decision Date 08/22/2007
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
Predetermined Change
Control Plan Authorized		 No
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