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FDA 510(k) Application Details - K192207
Device Classification Name
More FDA Info for this Device
510(K) Number
K192207
Device Name
Trevo NXT ProVue Retriever
Applicant
Stryker
47900 Bayside Parkway
Fremont, CA 94538 US
Other 510(k) Applications for this Company
Contact
Rhoda M Santos
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
POL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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