FDA 510(k) Application Details - K050446

Device Classification Name Barrier, Animal Source, Intraoral

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510(K) Number K050446
Device Name Barrier, Animal Source, Intraoral
Applicant ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE
1301 K STREET NW
SUITE 600
WASHINGTON, DC 20005 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 02/22/2005
Decision Date 08/09/2005
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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