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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Neuromuscular, External Functional
510(k) Number K213622
Device Name Cionic Neural Sleeve NS-100
Applicant
CIONIC
1606 Stockton St, Suite #1
San Francisco,  CA  94133
Applicant Contact Mihai Ionescu
Correspondent
CIONIC
1606 Stockton St, Suite #1
San Francisco,  CA  94133
Correspondent Contact Mihai Ionescu
Regulation Number882.5810
Classification Product Code
GZI  
Subsequent Product Code
IPF  
Date Received11/16/2021
Decision Date 02/14/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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