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FDA 510(k) Application Details - K071555
Device Classification Name
Barrier, Animal Source, Intraoral
More FDA Info for this Device
510(K) Number
K071555
Device Name
Barrier, Animal Source, Intraoral
Applicant
ORGANOGENESIS, INC.
150 DAN RD.
CANTON, MA 02021 US
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Contact
PATRICK R BILBO
Other 510(k) Applications for this Contact
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
06/07/2007
Decision Date
08/30/2007
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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