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510(k) K931678

ORTHOMET LHMC FEMORAL STEM by Orthomet, Inc. — Product Code HMC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1994
Date Received
April 6, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Eye Movement, Diagnostic
Device Class
Class II
Regulation Number
886.1510
Review Panel
OP
Submission Type

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  • K931333 — ORTHOMET ACETABULAR CUP SYSTEM (October 14, 1994)
  • K925536 — HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM (January 7, 1994)
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