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510(k) K041858

ACUMED ANATOMIC RADIAL HEAD SYSTEM by Acumed, LLC — Product Code KWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2004
Date Received
July 9, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Elbow, Hemi-, Radial, Polymer
Device Class
Class II
Regulation Number
888.3170
Review Panel
OR
Submission Type

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