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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 K032965
Device Name LAPAROSCOPIC INSTRUMENT, ELECTRODE AND CABLE
Applicant
Modern Medical Equipment Mfg., Ltd.
5/F Gold King Ind. Bldg. 35
Tai Lin Pai Rd.
Kwai Chung N.T.,  HK
Applicant Contact DAVID LOU
Correspondent
Modern Medical Equipment Mfg., Ltd.
5/F Gold King Ind. Bldg. 35
Tai Lin Pai Rd.
Kwai Chung N.T.,  HK
Correspondent Contact DAVID LOU
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/23/2003
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
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