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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Irrigation, Urological
510(k) Number K070873
Device Name AMSURE BLADDER IRRIGATION SET
Applicant
Amsino Intl., Inc.
855 Towne Center Dr.
Pomona,  CA  91765
Applicant Contact YI CHEN
Correspondent
Amsino Intl., Inc.
855 Towne Center Dr.
Pomona,  CA  91765
Correspondent Contact YI CHEN
Regulation Number876.5130
Classification Product Code
LJH  
Date Received03/29/2007
Decision Date 12/19/2007
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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