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FDA 510(k) Application Details - K010320
Device Classification Name
Bone Grafting Material, Synthetic
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510(K) Number
K010320
Device Name
Bone Grafting Material, Synthetic
Applicant
DEPUY ACROMED
325 PARAMOUNT DR.
RAYNHAM, MA 02767-0350 US
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Contact
KAREN F JURCZAK
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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
02/02/2001
Decision Date
03/01/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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