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FDA 510(k) Application Details - K081253
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K081253
Device Name
Powder, Porcelain
Applicant
C5 MEDICAL WERKS, INC.
2451 RIVER RD.
GRAND JUNCTION, CO 81505 US
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Contact
HOMER GREGORY
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
05/02/2008
Decision Date
05/15/2008
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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