FDA 510(k) Application Details - K150416

Device Classification Name Pin, Fixation, Smooth

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510(K) Number K150416
Device Name Pin, Fixation, Smooth
Applicant STRYKER ENDOSCOPY
5900 OPTICAL COURT
SAN JOSE, CA 95138 US
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Contact KELLY KUCHARCZYK
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Regulation Number 888.3040

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Classification Product Code HTY
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Date Received 02/18/2015
Decision Date 04/17/2015
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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