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FDA 510(k) Application Details - K091120
Device Classification Name
Barrier, Synthetic, Intraoral
More FDA Info for this Device
510(K) Number
K091120
Device Name
Barrier, Synthetic, Intraoral
Applicant
POREX SURGICAL, INC.
15 DART RD.
NEWNAN, GA 30265 US
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Contact
JERRI L MANN
Other 510(k) Applications for this Contact
Regulation Number
872.3930
More FDA Info for this Regulation Number
Classification Product Code
NPK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/17/2009
Decision Date
03/19/2010
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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