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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 K171747
Device Name MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil
Applicant
Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham,  MA  02767
Applicant Contact Vivian Perez
Correspondent
Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham,  MA  02767
Correspondent Contact Yolanda Bolanos
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received06/13/2017
Decision Date 07/14/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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