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510(k) K994326

ASCENT KNEE SYSTEM by Biomet Manufacturing, Inc. — Product Code KWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2000
Date Received
December 22, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Toe, Constrained, Polymer
Device Class
Class II
Regulation Number
888.3720
Review Panel
OR
Submission Type

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