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FDA 510(k) Application Details - K000764
Device Classification Name
Nail, Fixation, Bone
More FDA Info for this Device
510(K) Number
K000764
Device Name
Nail, Fixation, Bone
Applicant
BIOMET, INC.
P.O. BOX 587
AIRPORT INDUSTRIAL PARK
WARSAW, IN 46581-0587 US
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PATRICIA SANDBORN BERES
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
JDS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/09/2000
Decision Date
04/06/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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