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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 K161429
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 Received05/23/2016
Decision Date 06/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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