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FDA 510(k) Application Details - K141029
Device Classification Name
More FDA Info for this Device
510(K) Number
K141029
Device Name
TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM
Applicant
TORNIER, INC.
10801 Nesbitt Avenue South
Bloomington, MN 55437 US
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Contact
KRISTINE TUCKER
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PHX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/22/2014
Decision Date
06/18/2014
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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