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510(k) K014049

EPOCA CODR STEM AND HEAD by Stelkast Company — Product Code KWT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2002
Date Received
December 10, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Device Class
Class II
Regulation Number
888.3650
Review Panel
OR
Submission Type

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