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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 K032061
Device Name DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH
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 Received07/03/2003
Decision Date 12/23/2003
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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