FDA 510(k) Application Details - K103121

Device Classification Name Sealant, Pit And Fissure, And Conditioner

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510(K) Number K103121
Device Name Sealant, Pit And Fissure, And Conditioner
Applicant VERICOM CO., LTD.
#606,5TH DONGYOUNG VENTURESTEL
199-32, ANYANG 7-DONG,MANAN-GU
ANYANG-SI, GYEONGGI-DO 430-817 KR
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Contact MYUNG-HWAN OH
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Regulation Number 872.3765

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Classification Product Code EBC
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Date Received 10/22/2010
Decision Date 10/26/2010
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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