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FDA 510(k) Application Details - K192448
Device Classification Name
More FDA Info for this Device
510(K) Number
K192448
Device Name
Delta Xtend Revers Shoulder System
Applicant
DePuy(Ireland)
Loughbeg Ringaskiddy
Co.Cork Munster IE
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Contact
Ashley Goncalo
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
PHX
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Date Received
09/06/2019
Decision Date
10/04/2019
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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