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510(k) K974331

UNI-ROM TOTAL HIP SYSTEM FEMORAL STEM by Johnson & Johnson Professionals, Inc. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1998
Date Received
November 18, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type

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