FDA 510(k) Application Details - K021844

Device Classification Name Sealant, Pit And Fissure, And Conditioner

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510(K) Number K021844
Device Name Sealant, Pit And Fissure, And Conditioner
Applicant VOCO GMBH
19379 BLUE LAKE LOOP
BEND, OR 97702 US
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Contact GERALD W SHIPPS
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Regulation Number 872.3765

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Classification Product Code EBC
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Date Received 06/05/2002
Decision Date 07/19/2002
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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