FDA 510(k) Application Details - K192207

Device Classification Name

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510(K) Number K192207
Device Name Trevo NXT ProVue Retriever
Applicant Stryker
47900 Bayside Parkway
Fremont, CA 94538 US
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Contact Rhoda M Santos
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Regulation Number

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Classification Product Code POL
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Date Received 08/14/2019
Decision Date 11/22/2019
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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