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FDA 510(k) Application Details - K123695
Device Classification Name
Handpiece, Water-Powered
More FDA Info for this Device
510(K) Number
K123695
Device Name
Handpiece, Water-Powered
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
EKY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/03/2012
Decision Date
12/18/2012
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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