FDA 510(k) Application Details - K033697

Device Classification Name Activator, Ultraviolet, For Polymerization

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510(K) Number K033697
Device Name Activator, Ultraviolet, For Polymerization
Applicant DENTAL PRODUCTS OF USA, INC.
1460 N.W. 107 AVE., SUITE G
MIAMI, FL 33174 US
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Contact GEORGE ECHEVERRI
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Regulation Number 872.6070

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Classification Product Code EBZ
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Date Received 11/25/2003
Decision Date 02/27/2004
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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