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FDA 510(k) Application Details - K093560
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K093560
Device Name
Powder, Porcelain
Applicant
SHENYANG UPCERA CO., LTD.
1705 S. CAPITAL OF TEXAS HWY
SUITE 500
AUSTIN, TX 78746 US
Other 510(k) Applications for this Company
Contact
STUART R GOLDMAN
Other 510(k) Applications for this Contact
Regulation Number
872.6660
More FDA Info for this Regulation Number
Classification Product Code
EIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/18/2009
Decision Date
01/28/2010
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
N
Expedited Review
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