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510(k) K042035

ALUMINA HEAD by Fournitures Hospitalieres Industrie — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2004
Date Received
July 29, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

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