FDA 510(k) Application Details - K040098

Device Classification Name Varnish, Cavity

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510(K) Number K040098
Device Name Varnish, Cavity
Applicant MEDICAL PRODUCTS LABORATORIES, INC.
9990 GLOBAL RD.
PHILADELPHIA, PA 19115 US
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Contact ROBERT J MALERMAN
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Regulation Number 872.3260

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Classification Product Code LBH
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Date Received 01/20/2004
Decision Date 02/04/2004
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 Y
Expedited Review



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