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FDA 510(k) Application Details - K103755
Device Classification Name
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
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510(K) Number
K103755
Device Name
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Applicant
BIOMET MANUFACTURING CORP.
PO BOX 587
WARSAW, IN 46581-0587 US
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Contact
BECKY EARL
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Regulation Number
888.3330
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Classification Product Code
KWA
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More FDA Info for this Product Code
Date Received
12/23/2010
Decision Date
01/21/2011
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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