FDA 510(k) Application Details - K073043

Device Classification Name Cement, Dental

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510(K) Number K073043
Device Name Cement, Dental
Applicant SDI LTD.
5-9 BRUNSDON ST.
BAYSWATER, VICTORIA 3153 AU
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Contact RAY CAHILL
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Regulation Number 872.3275

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Classification Product Code EMA
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Date Received 10/29/2007
Decision Date 12/14/2007
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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