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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Evacuator, Fluid
510(k) Number K093479
FOIA Releasable 510(k) K093479
Device Name DISPOSABLE SUCTION AND IRRIGATION SYSTEM
Applicant
Modern Medical Equipment Mfg., Ltd.
Dong Xing Industrial Area
Kang Le Lu, Shan Xia District
Heng Li, Dongguan, Guangdong,  CN 523466
Applicant Contact EUGENE YEUNG
Correspondent
Modern Medical Equipment Mfg., Ltd.
Dong Xing Industrial Area
Kang Le Lu, Shan Xia District
Heng Li, Dongguan, Guangdong,  CN 523466
Correspondent Contact EUGENE YEUNG
Regulation Number876.4370
Classification Product Code
FHF  
Date Received11/09/2009
Decision Date 05/19/2010
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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