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FDA 510(k) Application Details - K092758
Device Classification Name
Controller, Foot, Handpiece And Cord
More FDA Info for this Device
510(K) Number
K092758
Device Name
Controller, Foot, Handpiece And Cord
Applicant
SAESHIN PRECISION CO., LTD.
#93-15, PAHO-DONG, DALSEO-GU
DAEGU 704-220 KR
Other 510(k) Applications for this Company
Contact
Y.S. LEE
Other 510(k) Applications for this Contact
Regulation Number
872.4200
More FDA Info for this Regulation Number
Classification Product Code
EBW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/09/2009
Decision Date
09/21/2009
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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