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FDA 510(k) Application Details - K071485
Device Classification Name
Unit, Operative Dental
More FDA Info for this Device
510(K) Number
K071485
Device Name
Unit, Operative Dental
Applicant
TPC ADVANCED TECHNOLOGY, INC.
18525 EAST GALE AVE.
CITY OF INDUSTRY, CA 91748 US
Other 510(k) Applications for this Company
Contact
SCOTT BECKLEY
Other 510(k) Applications for this Contact
Regulation Number
872.6640
More FDA Info for this Regulation Number
Classification Product Code
EIA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/30/2007
Decision Date
08/28/2007
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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