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510(k) K051826

BETACONE HIP PROSTHESIS SYSTEM by Waldemar Link GmbH & Co. KG — Product Code LWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2005
Date Received
July 5, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type

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