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FDA 510(k) Application Details - K123608
Device Classification Name
Controller, Foot, Handpiece And Cord
More FDA Info for this Device
510(K) Number
K123608
Device Name
Controller, Foot, Handpiece And Cord
Applicant
SAEYANG MICROTECH CO., LTD
55 NORTHERN BLVD
GREAT NECK, NY 11021 US
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Contact
JIGAR SHAH
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
11/21/2012
Decision Date
08/16/2013
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
N
Expedited Review
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