FDA 510(k) Application Details - K012423

Device Classification Name Barrier, Animal Source, Intraoral

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510(K) Number K012423
Device Name Barrier, Animal Source, Intraoral
Applicant ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE
1050 CONNECTICUT AVE. NW
WASHINGTON, DC 20036 US
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Contact PETER S REICHERTZ
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Regulation Number 872.3930

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Classification Product Code NPL
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Date Received 07/30/2001
Decision Date 01/24/2003
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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