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FDA 510(k) Application Details - K002998
Device Classification Name
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
More FDA Info for this Device
510(K) Number
K002998
Device Name
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Applicant
BIOMET, INC.
AIRPORT INDUSTRIAL PARK,
P.O.BOX 587
WARSAW, IN 46581-0587 US
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Contact
TRACY J BICKE;
Other 510(k) Applications for this Contact
Regulation Number
888.3650
More FDA Info for this Regulation Number
Classification Product Code
KWT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/26/2000
Decision Date
10/06/2000
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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