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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 K102043
Device Name ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER
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 Received07/20/2010
Decision Date 11/18/2010
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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