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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrosurgical, Active, Urological
510(k) Number K091511
Device Name MODERN MEDICAL RESECTOSCOPE ELECTRODES
Applicant
Modern Medical Equipment Mfg., Ltd.
35 Tai Lin Pai Rd.
Kwai Chung, Hong Kong,  CN
Applicant Contact EUGENE YEUNG
Correspondent
Modern Medical Equipment Mfg., Ltd.
35 Tai Lin Pai Rd.
Kwai Chung, Hong Kong,  CN
Correspondent Contact EUGENE YEUNG
Regulation Number876.4300
Classification Product Code
FAS  
Date Received05/22/2009
Decision Date 01/15/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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