FDA 510(k) Application Details - K070561

Device Classification Name Pin, Fixation, Smooth

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510(K) Number K070561
Device Name Pin, Fixation, Smooth
Applicant TELEFLEX MEDICAL
2345 WAUKEGAN ROAD
SUITE 120
BANNOCKBURN, IL 60015 US
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Contact LORI HAYS
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Regulation Number 888.3040

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Classification Product Code HTY
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Date Received 02/27/2007
Decision Date 05/25/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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