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510(k) K953273

BIOPLATE RIGID FIXATION BONE PLATING SYSTEM by Biomedics — Product Code JEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1995
Date Received
July 13, 1995
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

Other clearances by Biomedics

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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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