FDA 510(k) Application Details - K052294

Device Classification Name Plate, Fixation, Bone

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510(K) Number K052294
Device Name Plate, Fixation, Bone
Applicant HAND INNOVATIONS, LLC.
8905 SW 87TH AVENUE
SUITE 220
MIAMI, FL 33176 US
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Contact ERNESTO HERNANDEZ
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Regulation Number 888.3030

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Classification Product Code HRS
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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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