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FDA 510(k) Application Details - K032110
Device Classification Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
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510(K) Number
K032110
Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Applicant
STELKAST COMPANY
200 HIDDEN VALLEY RD.
MCMURRAY, PA 15317 US
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Contact
DONALD A STEVENS
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Regulation Number
888.3360
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Classification Product Code
LWJ
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More FDA Info for this Product Code
Date Received
07/09/2003
Decision Date
09/22/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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