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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K033003
Device Name SUCTION COAGULATOR
Applicant
Modern Medical Equipment Mfg., Ltd.
Tai Lin Pai Rd.
Kwai Chung, Hong Kong,  CN
Applicant Contact DAVID LOU
Correspondent
Modern Medical Equipment Mfg., Ltd.
Tai Lin Pai Rd.
Kwai Chung, Hong Kong,  CN
Correspondent Contact DAVID LOU
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/25/2003
Decision Date 05/13/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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