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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Neurovascular Embolization
510(k) Number K153658
Device Name Target Detachable Coils
Applicant
Stryker Neurovascular
47900 Bayside Parkway
Fremont,  CA  94538 -2588
Applicant Contact Kate Taylor
Correspondent
Stryker Neurovascular
47900 Bayside Parkway
Fremont,  CA  94538 -2588
Correspondent Contact Kate Taylor
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received12/21/2015
Decision Date 05/19/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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