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FDA 510(k) Application Details - K030195
Device Classification Name
Bone Grafting Material, Synthetic
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510(K) Number
K030195
Device Name
Bone Grafting Material, Synthetic
Applicant
OCT, USA, INC.
13 RED FOX LN.
LITTLETON, CO 80127 US
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Contact
Kevin Walls
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Regulation Number
872.3930
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Classification Product Code
LYC
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More FDA Info for this Product Code
Date Received
01/21/2003
Decision Date
06/17/2004
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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