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510(k) K851349

LERE NAIL & PLATE COMBIN. ONE PIECE FORGED by Medicalex — Product Code KTW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1985
Date Received
April 4, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Medicalex

  • K850946 — SURGICAL ASPIRATOR (September 16, 1985)
  • K833377 — MEDICALEX (September 27, 1984)
  • K831728 — MEDICALEX (January 9, 1984)

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