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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 K223603
Device Name Reflow System Mini and ReFlow Mini Flusher
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 Chi Eagleburger
Regulation Number882.5550
Classification Product Code
JXG  
Date Received12/02/2022
Decision Date 12/29/2022
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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