FDA 510(k) Application Details - K130298

Device Classification Name Pin, Fixation, Threaded

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510(K) Number K130298
Device Name Pin, Fixation, Threaded
Applicant BIOPRO, INC.
3150 E. 200TH ST
PRIOR LAKE, MN 55372 US
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Contact AL LIPPINCOTT
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Regulation Number 888.3040

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Classification Product Code JDW
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Date Received 02/07/2013
Decision Date 06/18/2013
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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