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FDA 510(k) Application Details - K021878
Device Classification Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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510(K) Number
K021878
Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Applicant
ESKA AMERICA CORP.
101 RIVERFRONT BLVD.
BRADENTON, FL 34205-8802 US
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Contact
THOMAS P MONKUS
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Regulation Number
888.3358
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Classification Product Code
LPH
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More FDA Info for this Product Code
Date Received
06/07/2002
Decision Date
03/04/2003
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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