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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K110390
Device Name ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR
Applicant
Handelshaus Dittman GmbH
#3 Bldg.,Xiliyiangguang
Industrial Estate Xillixaobaim
Shenzhen,  CN 518108
Applicant Contact KANG JIANG PING
Correspondent
Handelshaus Dittman GmbH
#3 Bldg.,Xiliyiangguang
Industrial Estate Xillixaobaim
Shenzhen,  CN 518108
Correspondent Contact KANG JIANG PING
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Code
IPF  
Date Received02/11/2011
Decision Date 07/29/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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