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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K093653
Device Name URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK
Applicant
URESIL, LLC
5418 WEST TOUHY AVE.
SKOKIE,  IL  60077
Applicant Contact LEV MELINYSHYN
Correspondent
URESIL, LLC
5418 WEST TOUHY AVE.
SKOKIE,  IL  60077
Correspondent Contact LEV MELINYSHYN
Regulation Number876.5980
Classification Product Code
KNT  
Date Received11/25/2009
Decision Date 02/23/2010
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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