FDA 510(k) Application Details - K202522

Device Classification Name Guide, Wire, Catheter, Neurovasculature

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510(K) Number K202522
Device Name Guide, Wire, Catheter, Neurovasculature
Applicant STRYKER NEUROVASCULAR
47900 Bayside Parkway
Fremont, CA 94538 US
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Contact Hailey Hinkle
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Regulation Number 870.1330

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Classification Product Code MOF
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Date Received 09/01/2020
Decision Date 09/25/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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