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510(k) K960482

K-WIRE by American Medical Specialties, Inc. — Product Code HTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1996
Date Received
February 2, 1996
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 American Medical Specialties, Inc.

  • K960483 — STEINMAN PIN (April 9, 1996)
  • K934603 — SURGICAL SAW BLADES (February 22, 1994)
  • K934583 — BURRS (January 26, 1994)

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