FDA 510(k) Application Details - K063646

Device Classification Name Unit, Operative Dental

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510(K) Number K063646
Device Name Unit, Operative Dental
Applicant CAMSIGHT CO., INC.
3380 SAN FERNADO ROAD
LOS ANGELES, CA 90065 US
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Contact JAY CHOI
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Regulation Number 872.6640

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Classification Product Code EIA
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Date Received 12/07/2006
Decision Date 03/07/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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