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FDA 510(k) Application Details - K071858
Device Classification Name
Instruments, Dental Hand
More FDA Info for this Device
510(K) Number
K071858
Device Name
Instruments, Dental Hand
Applicant
FLY CAST TECHNOLOGIES, INC.
P.O. BOX 848
GRAYSLAKE, IL 60030 US
Other 510(k) Applications for this Company
Contact
MICHELE H VOVOLKA
Other 510(k) Applications for this Contact
Regulation Number
872.4565
More FDA Info for this Regulation Number
Classification Product Code
DZN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/05/2007
Decision Date
08/31/2007
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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