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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 K063441
Device Name 15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55
Applicant
Spire Biomedical, Inc.
One Patriots Park
Bedford,  MA  01730
Applicant Contact SHEKHAR NIMKAR
Correspondent
Spire Biomedical, Inc.
One Patriots Park
Bedford,  MA  01730
Correspondent Contact SHEKHAR NIMKAR
Regulation Number876.5540
Classification Product Code
MSD  
Date Received11/14/2006
Decision Date 02/12/2007
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 Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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