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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 K211344
Device Name MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems
Applicant
Medos International SARL
Chemin-Blanc 38
Le Locle,  CH 2400
Applicant Contact Ariell Joiner
Correspondent
CERENOVUS
6303 Blue Lagoon Drive, Suite 315
Miami,  FL  33126
Correspondent Contact Ariell Joiner
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received05/03/2021
Decision Date 05/28/2021
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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