FDA 510(k) Application Details - K072298

Device Classification Name Staple, Fixation, Bone

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510(K) Number K072298
Device Name Staple, Fixation, Bone
Applicant BIOPRO, INC.
17 SEVENTEENTH ST.
PORT HURON, MI 48060 US
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Contact DAVID MRAK
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Regulation Number 888.3030

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Classification Product Code JDR
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Date Received 08/17/2007
Decision Date 10/29/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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