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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Catheter, G-U
510(k) Number K052298
Device Name CYSTOGLIDE INTRODUCER SHEATH
Applicant
Percutaneous Systems, Incorporated
1300 Crittenden Lane
Suite 101
Mountain View,  CA  94043 -1359
Applicant Contact THOMAS LAWSON
Correspondent
Percutaneous Systems, Incorporated
1300 Crittenden Lane
Suite 101
Mountain View,  CA  94043 -1359
Correspondent Contact THOMAS LAWSON
Regulation Number876.5130
Classification Product Code
KNY  
Date Received08/23/2005
Decision Date 12/12/2006
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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