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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K140202
Device Name TRAUSIM DENTAL IMPLANT SYSTEM
Applicant
Jiangsu Trausim Medical Instrument
West Renmin Rd., Niutang Town, Wujin Dist.
Changzhou City, Jaingsu Provicne,  CN 213163
Applicant Contact LUO ZHICONG
Correspondent
Jiangsu Trausim Medical Instrument
West Renmin Rd., Niutang Town, Wujin Dist.
Changzhou City, Jaingsu Provicne,  CN 213163
Correspondent Contact LUO ZHICONG
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received01/27/2014
Decision Date 12/12/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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