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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., NO.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
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