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FDA 510(k) Application Details - K051075
Device Classification Name
More FDA Info for this Device
510(K) Number
K051075
Device Name
ENCORE REVERSE SHOULDER PROSTHESIS
Applicant
ENCORE MEDICAL, L.P.
9800 METRIC BLVD.
AUSTIN, TX 78758 US
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Contact
CHRISTIE SHUMAKER
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
PHX
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Date Received
04/27/2005
Decision Date
05/27/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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