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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, Non-Implanted
510(k) Number K063355
Device Name D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW
Applicant
Novosci Corp.
2828 N. Crescent Ridge Dr.
The Woodlands,  TX  77381 -3902
Applicant Contact DAVID MAKANANI
Correspondent
Novosci Corp.
2828 N. Crescent Ridge Dr.
The Woodlands,  TX  77381 -3902
Correspondent Contact DAVID MAKANANI
Regulation Number876.5540
Classification Product Code
MPB  
Date Received11/07/2006
Decision Date 07/27/2007
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
Recalls CDRH Recalls
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