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FDA 510(k) Application Details - K092412
Device Classification Name
Handpiece, Belt And/Or Gear Driven, Dental
More FDA Info for this Device
510(K) Number
K092412
Device Name
Handpiece, Belt And/Or Gear Driven, Dental
Applicant
SAESHIN PRECISION CO., LTD.
1007, BYUCKSAN 2CHA
481-10,GASAN-DONG,GEUMCHEON-GU
SEOUL KR
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Contact
SEONG NAM KIM
Other 510(k) Applications for this Contact
Regulation Number
872.4200
More FDA Info for this Regulation Number
Classification Product Code
EFA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/06/2009
Decision Date
09/03/2009
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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