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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shunt, Central Nervous System And Components
510(k) Number K221918
Device Name ReFlow System Mini
Applicant
Anuncia Medical, Inc.
1355 N Scottsdale Rd., Suite 370
Scottsdale,  AZ  85257
Applicant Contact Elsa Chi Abruzzo
Correspondent
Anuncia Medical, Inc.
1355 N Scottsdale Rd., Suite 370
Scottsdale,  AZ  85257
Correspondent Contact Natalie Eagleburger
Regulation Number882.5550
Classification Product Code
JXG  
Date Received07/01/2022
Decision Date 09/29/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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