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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Guide, Wire, Catheter, Neurovasculature
510(k) Number K190843
Device Name Synchro2 Support Guidewire
Applicant
Stryker
47900 Bayside Parkway
Fremont,  CA  94538
Applicant Contact Lorraine Mazzeo
Correspondent
Stryker
47900 Bayside Parkway
Fremont,  CA  94538
Correspondent Contact Lorraine Mazzeo
Regulation Number870.1330
Classification Product Code
MOF  
Subsequent Product Code
DQX  
Date Received04/01/2019
Decision Date 05/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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