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FDA 510(k) Application Details - K131657
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K131657
Device Name
Plate, Fixation, Bone
Applicant
FLOWER ORTHOPEDICS CORPORATION
1835 MARKET ST, 29TH FLOOR
PHILADELPHIA, PA 19103 US
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Contact
JANICE M HOGAN
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
HRS
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More FDA Info for this Product Code
Date Received
06/06/2013
Decision Date
08/22/2013
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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