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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name neurovascular mechanical thrombectomy device for acute ischemic stroke treatment
510(k) Number K200117
Device Name Trevo NXT ProVue Retriever
Applicant
Stryker
47900 Bayside Parkway
Fremont,  CA  94538
Applicant Contact Germaine Fu
Correspondent
Stryker
47900 Bayside Parkway
Fremont,  CA  94538
Correspondent Contact Germaine Fu
Regulation Number882.5600
Classification Product Code
POL  
Subsequent Product Code
NRY  
Date Received01/21/2020
Decision Date 02/07/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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