FDA 510(k) Application Details - K161744

Device Classification Name Rongeur, Manual

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510(K) Number K161744
Device Name Rongeur, Manual
Applicant Symmetry Surgical Inc.
3034 Owen Drive
Antioch, TN 37013 US
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Contact Lora Tjomstol
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Regulation Number 882.4840

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Classification Product Code HAE
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Date Received 06/24/2016
Decision Date 09/07/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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