FDA 510(k) Application Details - K030488

Device Classification Name Varnish, Cavity

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510(K) Number K030488
Device Name Varnish, Cavity
Applicant PASCAL CO., INC.
2929 N.E. NORTHUP WAY
BELLEVUE, WA 98004 US
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Contact VINCENT M TENTARELLI
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Regulation Number 872.3260

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Classification Product Code LBH
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Date Received 02/14/2003
Decision Date 05/02/2003
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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