FDA 510(k) Application Details - K142866

Device Classification Name Device, Surgical, Cryogenic

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510(K) Number K142866
Device Name Device, Surgical, Cryogenic
Applicant Myoscience, Inc
1600 Seaport Blvd, North Lobby, Suite 450
Redwood City, CA 940632 US
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Contact Tracey Henry
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Regulation Number 882.4250

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Classification Product Code GXH
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Date Received 10/01/2014
Decision Date 01/21/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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