FDA 510(k) Application Details - K092873

Device Classification Name

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510(K) Number K092873
Device Name REVERSE SHOULDER PROSTHESIS
Applicant DJO SURGICAL
9800 METRIC BOULEVARD
AUSTIN, TX 78758 US
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Contact TEFFANY HUTTO
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Regulation Number

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Classification Product Code PHX
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Date Received 09/18/2009
Decision Date 10/27/2009
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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