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FDA 510(k) Application Details - K132287
Device Classification Name
More FDA Info for this Device
510(K) Number
K132287
Device Name
JAZZ SYSTEM
Applicant
HOGAN LOVELLS US LLP
1835 MARKET ST 29TH FL
PHILADELPHIA, PA 19103 US
Other 510(k) Applications for this Company
Contact
JANICE M HOGAN
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
OWI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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