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510(k) K850401

LETOURNEL ACETABULAR PLATE by Pfizer, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1985
Date Received
February 1, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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  • K850443 — MEC ROD CONNECTOR (July 15, 1985)
  • K850403 — MEC DISTAL FEMORAL BOLT (July 15, 1985)

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