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510(k) K915445

MAALEABLE FACIAL IMPLANT by Biomet Ussc Orthopedics — Product Code KKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1992
Date Received
December 5, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Device Class
Class II
Regulation Number
878.3500
Review Panel
SU
Submission Type

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