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FDA 510(k) Application Details - K111816
Device Classification Name
Bone Grafting Material, Animal Source
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510(K) Number
K111816
Device Name
Bone Grafting Material, Animal Source
Applicant
LUITPOLD PHARMACEUTICALS, INC.
ONE LUITPOLD DR.
P.O. BOX 9001
SHIRLEY, NY 11967 US
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Contact
MARSHA SIMON
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Regulation Number
872.3930
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Classification Product Code
NPM
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More FDA Info for this Product Code
Date Received
06/27/2011
Decision Date
09/29/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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