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510(k) K844787

BIOMETRIC TOTAL HIP SYSTEM by Biomedics — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1985
Date Received
December 10, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
Review Panel
OR
Submission Type

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