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FDA 510(k) Application Details - K003494
Device Classification Name
Bone Grafting Material, Synthetic
More FDA Info for this Device
510(K) Number
K003494
Device Name
Bone Grafting Material, Synthetic
Applicant
BIOMET, INC.
AIRPORT INDUSTRIAL PARK,
P.O.BOX 587
WARSAW, IN 46581-0587 US
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Contact
MICHELLE L MCKINLEY
Other 510(k) Applications for this Contact
Regulation Number
872.3930
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Classification Product Code
LYC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/13/2000
Decision Date
04/09/2001
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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