FDA 510(k) Application Details - K162702

Device Classification Name Apparatus, Traction, Non-Powered

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510(K) Number K162702
Device Name Apparatus, Traction, Non-Powered
Applicant STL International, Inc.
9902 162nd Street, Court E
Puyallup, WA 98375 US
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Contact Rylie Teeter Leier
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Regulation Number 888.5850

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Classification Product Code HST
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Date Received 09/28/2016
Decision Date 12/30/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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