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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, operative dental
510(k) Number K103550
Device Name YOBOSHI DENTAL UNIT
Applicant
FOSHAM YOBOSHI MEDICAL EQUIPMENT CO., LTD
ROOM 2706, BLOCK A, ZHONGFANG
JINYUAN BUILDING, XINWEN ROAD
SHENZHEN, GUANGDONG,  CN 528500
Applicant Contact SABRINA WEI
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number872.6640
Classification Product Code
EIA  
Date Received12/03/2010
Decision Date 01/04/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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