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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Guidewire, Gastroenterology-Urology
510(k) Number K113692
Device Name XENX
Applicant
Xenolith Medical
1 Leshem,
P.O. Box 720
Kityat-Gat,  IL 82000
Applicant Contact OFER ZIGMAN
Correspondent
Xenolith Medical
1 Leshem,
P.O. Box 720
Kityat-Gat,  IL 82000
Correspondent Contact OFER ZIGMAN
Regulation Number876.1500
Classification Product Code
OCY  
Subsequent Product Code
FFL  
Date Received12/15/2011
Decision Date 08/09/2012
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 No
Predetermined Change
Control Plan Authorized		 No
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