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FDA 510(k) Application Details - K042021
Device Classification Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
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510(K) Number
K042021
Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Applicant
EXACTECH, INC.
2320 N.W. 66TH CT.
GAINESVILLE, FL 32653 US
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Contact
GARY MILLER
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Regulation Number
888.3660
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Classification Product Code
KWS
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More FDA Info for this Product Code
Date Received
07/28/2004
Decision Date
10/26/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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