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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 K060155
Device Name 15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS
Applicant
Spire Biomedical, Inc.
One Patriots Park
Bedford,  MA  01730 -2396
Applicant Contact DONALD FICKETT
Correspondent
Spire Biomedical, Inc.
One Patriots Park
Bedford,  MA  01730 -2396
Correspondent Contact DONALD FICKETT
Regulation Number876.5540
Classification Product Code
MSD  
Date Received01/20/2006
Decision Date 05/09/2006
Decision Substantially Equivalent (SESE)
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
Recalls CDRH Recalls
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