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FDA 510(k) Application Details - K103550
Device Classification Name
Unit, Operative Dental
More FDA Info for this Device
510(K) Number
K103550
Device Name
Unit, Operative Dental
Applicant
FOSHAM YOBOSHI MEDICAL EQUIPMENT CO., LTD
ROOM 2706, BLOCK A, ZHONGFANG
JINYUAN BUILDING, XINWEN ROAD
SHENZHEN, GUANGDONG 528500 CN
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Contact
SABRINA WEI
Other 510(k) Applications for this Contact
Regulation Number
872.6640
More FDA Info for this Regulation Number
Classification Product Code
EIA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/03/2010
Decision Date
01/04/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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