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FDA 510(k) Application Details - K050170
Device Classification Name
Bone Grafting Material, Synthetic
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510(K) Number
K050170
Device Name
Bone Grafting Material, Synthetic
Applicant
BIOCOMPOSITES LTD.
KEELE SCIENCE PARK
KEELE, STAFFORDSHIRE ST5 5NL GB
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Contact
SIMON FITZER
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Regulation Number
872.3930
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Classification Product Code
LYC
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Date Received
01/26/2005
Decision Date
08/26/2005
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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