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FDA 510(k) Application Details - K030867
Device Classification Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
More FDA Info for this Device
510(K) Number
K030867
Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Applicant
ESKA IMPLANTS GMBH
101 RIVERFRONT BLVD.
SUITE 600
BRADENTON, FL 34205 US
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Contact
THOMAS P MONKUS
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Regulation Number
888.3350
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Classification Product Code
JDI
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More FDA Info for this Product Code
Date Received
03/19/2003
Decision Date
09/22/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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