FDA 510(k) Application Details - K030605

Device Classification Name Lock, Wire, And Ligature, Intraoral

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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
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Regulation Number 872.4600

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Classification Product Code DYX
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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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