FDA 510(k) Application Details - K102531

Device Classification Name Barrier, Animal Source, Intraoral

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510(K) Number K102531
Device Name Barrier, Animal Source, Intraoral
Applicant ED. GEISTLICH SOEHNE AG FUR CHEMISCHE INDUSTRIE
1300 I STREET, N.W., 11TH FL
EAST
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 09/03/2010
Decision Date 11/17/2010
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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