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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Repair, Catheter, Hemodialysis
510(k) Number K092797
Device Name ACUTE AND CHRONIC CATHETER REPAIR KIT
Applicant
Kendall
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact Daniel Campion
Correspondent
Kendall
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact Daniel Campion
Regulation Number876.5540
Classification Product Code
NFK  
Date Received09/11/2009
Decision Date 11/19/2009
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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