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510(k) K961732

KAR by Landos, Inc. — Product Code MEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1997
Date Received
May 3, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K960642 — NANCY NAIL (May 17, 1996)
  • K943727 — BIOSTOP G BONE CEMENT RESTRICTOR (May 11, 1995)

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