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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, Orthodontic
510(k) Number K152297
Device Name OBS Anchorage Screw
Applicant
Bomei Co, Ltd.
4f., #1492-2, Chunrih Rd., Taoyuan Dist.
Taoyuan City,  TW 33051
Applicant Contact LINNEY CHIANG
Correspondent
Shaoyin Peng
258 N Bay Dr.
Bullard,  TX  75757
Correspondent Contact SHAOYIN PENG
Regulation Number872.3640
Classification Product Code
OAT  
Date Received08/13/2015
Decision Date 02/09/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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