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510(k) K093599

ARROW ANATOMICAL SHOULDER SYSTEM by Fournitures Hospitalieres Industrie — Product Code KWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2010
Date Received
November 20, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device Class
Class II
Regulation Number
888.3660
Review Panel
OR
Submission Type

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