FDA 510(k) Application Details - K042124

Device Classification Name Material, Tooth Shade, Resin

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510(K) Number K042124
Device Name Material, Tooth Shade, Resin
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 872.3690

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Classification Product Code EBF
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Date Received 08/06/2004
Decision Date 08/13/2004
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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