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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dislodger, Stone, Basket, Ureteral, Metal
510(k) Number K052048
Device Name ACCORDION
Applicant
Percutaneous Systems, Incorporated
1300 Crittenden Lane
Suite 301
Mountain View,  CA  94043
Applicant Contact THOMAS LAWSON
Correspondent
Percutaneous Systems, Incorporated
1300 Crittenden Lane
Suite 301
Mountain View,  CA  94043
Correspondent Contact THOMAS LAWSON
Regulation Number876.4680
Classification Product Code
FFL  
Date Received07/29/2005
Decision Date 09/13/2005
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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