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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dissolvable Gel For Preventing Ureteral Stone Migration
510(k) Number K090430
Device Name BACKSTOP AND BACKSTOP INJECTOR
Applicant
Pluromed, Inc.
25-H Olympia Ave.
Woburn,  MA  01801
Applicant Contact JAMES WILKIE
Correspondent
Pluromed, Inc.
25-H Olympia Ave.
Woburn,  MA  01801
Correspondent Contact JAMES WILKIE
Regulation Number876.4680
Classification Product Code
ONJ  
Date Received02/19/2009
Decision Date 06/02/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT00893282
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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