FDA 510(k) Application Details - K012427

Device Classification Name Tester, Pulp

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510(K) Number K012427
Device Name Tester, Pulp
Applicant SPECIALITES SEPTODONT
1050 CONNECTICUT AVE. NW
WASHINGTON, DC 20036-5339 US
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Contact PETER S REICHERTZ
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Regulation Number 872.1720

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Classification Product Code EAT
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Date Received 07/31/2001
Decision Date 10/09/2001
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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