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510(k) K911505

FIXATION WIRE by Simpex, Inc. — Product Code HTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1991
Date Received
April 4, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Smooth
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Simpex, Inc.

  • K920174 — EASY TOUCH LATEX EAM GLOVES (April 22, 1992)
  • K913793 — SIMPEX INC. ORAL AND RECTAL THERMOMETERS (December 30, 1991)
  • K913794 — SIMPEX INC. SURGICAL DRESSING (November 20, 1991)
  • K911452 — FIXATION PIN (April 12, 1991)

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