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FDA 510(k) Application Details - K080305
Device Classification Name
Material, Tooth Shade, Resin
More FDA Info for this Device
510(K) Number
K080305
Device Name
Material, Tooth Shade, Resin
Applicant
META BIOMED CO., LTD.
414-12 MO CHOONG DONG
CHEONG JU
CHEUNG CITY, CHUNG BUK 441-12 KR
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Contact
TAE-HOON KIM
Other 510(k) Applications for this Contact
Regulation Number
872.3690
More FDA Info for this Regulation Number
Classification Product Code
EBF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/05/2008
Decision Date
04/07/2008
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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