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510(k) K961976

THE BIOPLATE FIXATION SYSTEM by Biomedics — Product Code JEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1996
Date Received
May 20, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Bone
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type

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  • K972463 — THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY (September 25, 1997)
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  • K842687 — BIOMEDICS BLADDER SCANNER (April 8, 1985)
  • K801345 — KAMPNER HINGED TOE PROSTHESIS (July 8, 1980)

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