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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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More FDA Info for this Product Code
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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