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FDA 510(k) Application Details - K030859
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K030859
Device Name
Powder, Porcelain
Applicant
ENAMELITE LLC
1800 BUSINESS PARK DR.
SUITE 406
CLARKSVILLE, TN 37040 US
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Contact
PHILLIP PITTS
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
03/18/2003
Decision Date
03/27/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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