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FDA 510(k) Application Details - K030605
Device Classification Name
Lock, Wire, And Ligature, Intraoral
More FDA Info for this Device
510(K) Number
K030605
Device Name
Lock, Wire, And Ligature, Intraoral
Applicant
ZYGOMATICS LTD.
20A MONTPELIER VALE
LONDON SE3 0TA GB
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Contact
CAROL MACDONALD
Other 510(k) Applications for this Contact
Regulation Number
872.4600
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Classification Product Code
DYX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/25/2003
Decision Date
06/27/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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