FDA 510(k) Application Details - K080687

Device Classification Name Bur, Dental

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510(K) Number K080687
Device Name Bur, Dental
Applicant S.S. WHITE BURS, INC.
1145 TOWBIN AVE.
LAKEWOOD, NJ 08701 US
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Contact DEREK GLADDEN
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Regulation Number 872.3240

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Classification Product Code EJL
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Date Received 03/11/2008
Decision Date 06/20/2008
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

FDA Source Information for K080687


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