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510(k) K042902

HERBERT ULNAR HEAD PROSTHESIS SYSTEM by Stuckenbrock Medizintechnik GmbH — Product Code KXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2004
Date Received
October 20, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Wrist, Hemi-, Ulnar
Device Class
Class II
Regulation Number
888.3810
Review Panel
OR
Submission Type

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