FDA 510(k) Application Details - K001878

Device Classification Name Unit, Operative Dental

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510(K) Number K001878
Device Name Unit, Operative Dental
Applicant WATERCLAVE, L.L.C.
8045 BIG BEND BLVD., SUITE 203
WEBSTER GROVES, MO 63119-2714 US
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Contact M. JOSEPH OLK
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Regulation Number 872.6640

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Classification Product Code EIA
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Date Received 06/20/2000
Decision Date 08/03/2000
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



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