FDA 510(k) Application Details - K132287

Device Classification Name

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510(K) Number K132287
Device Name JAZZ SYSTEM
Applicant HOGAN LOVELLS US LLP
1835 MARKET ST 29TH FL
PHILADELPHIA, PA 19103 US
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Contact JANICE M HOGAN
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Regulation Number

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Classification Product Code OWI
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Date Received 07/23/2013
Decision Date 09/25/2013
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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