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FDA 510(k) Application Details - K052294
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K052294
Device Name
Plate, Fixation, Bone
Applicant
HAND INNOVATIONS, LLC.
8905 SW 87TH AVENUE
SUITE 220
MIAMI, FL 33176 US
Other 510(k) Applications for this Company
Contact
ERNESTO HERNANDEZ
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
08/23/2005
Decision Date
10/21/2005
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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