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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Ward Use, Portable, Ac-Powered
510(k) Number K112421
Device Name EMG SUCTION UNIT
Applicant
Emg Technology Co., Ltd.
#58, 35 Rd., Taichung
Industrial Park, Shituen Chiu
Taichung,  TW 40768
Applicant Contact PAUL CHO
Correspondent
Underwriters Laboratories, Inc.
1285 Walt Whitman Rd.
Melville,  NY  11747
Correspondent Contact MARC M MOUSER
Regulation Number878.4780
Classification Product Code
JCX  
Date Received08/23/2011
Decision Date 09/01/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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