FDA 510(k) Application Details - K033068

Device Classification Name Cement, Dental

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510(K) Number K033068
Device Name Cement, Dental
Applicant VOCO GMBH
19379 BLUE LAKE LOOP
BEND, OR 97702 US
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Contact GERALD W SHIPPS
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Regulation Number 872.3275

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Classification Product Code EMA
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Date Received 09/29/2003
Decision Date 10/31/2003
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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