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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 K134006
Device Name DISPOSABLE LAPAROSCOPIC ELECTRODE, DISPOSABLE LAPAROSCOPIC ELECTRODE
Applicant
Modern Medical Equipment Manufacturing Limited
35-41 Tai Lin Pai Rd., 5f Gold King Industrial Bldg.
Kwai Chung
Hong Kong,  CN CH
Applicant Contact THOMAS CHAN TSZ FUNG
Correspondent
Modern Medical Equipment Manufacturing Limited
35-41 Tai Lin Pai Rd., 5f Gold King Industrial Bldg.
Kwai Chung
Hong Kong,  CN CH
Correspondent Contact THOMAS CHAN TSZ FUNG
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/27/2013
Decision Date 11/21/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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