FDA 510(k) Application Details - K203219

Device Classification Name

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510(K) Number K203219
Device Name Trevo XP ProVue Retriever and Trevo NXTÖ ProVue Retriever
Applicant Stryker Neurovascular
47900 Bayside Parkway
Fremont, CA 94538 US
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Contact Kathy Nguyen
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Regulation Number

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Classification Product Code POL
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Date Received 11/02/2020
Decision Date 12/29/2020
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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