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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 K082803
Device Name COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015
Applicant
Percutaneous Systems, Inc.
3260 Hill View Ave.
Palo Alto,  CA  94304
Applicant Contact THOMAS LAWSON
Correspondent
Percutaneous Systems, Inc.
3260 Hill View Ave.
Palo Alto,  CA  94304
Correspondent Contact THOMAS LAWSON
Regulation Number876.4680
Classification Product Code
FFL  
Date Received09/24/2008
Decision Date 11/13/2008
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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