FDA 510(k) Application Details - K100707

Device Classification Name Pin, Fixation, Threaded, Metallic

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510(K) Number K100707
Device Name Pin, Fixation, Threaded, Metallic
Applicant STERILMED, INC.
11400 73RD AVE. N.
MAPLE GROVE, MN 55369 US
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Contact GARRETT AHLBORG
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Regulation Number 888.3040

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Classification Product Code NDM
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Date Received 03/12/2010
Decision Date 06/25/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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