FDA 510(k) Application Details - K070289

Device Classification Name Varnish, Cavity

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510(K) Number K070289
Device Name Varnish, Cavity
Applicant ACQUAMED TECHNOLOGIES, INC.
33 WEST 480 FABYAN PARKWAY,
UNIT 105
WEST CHICAGO,, IL 60185 US
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Contact HUGH PALMER
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Regulation Number 872.3260

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Classification Product Code LBH
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Date Received 01/30/2007
Decision Date 05/04/2007
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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