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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dura Substitute
510(k) Number K223445
Device Name ArtiFascia
Applicant
Nurami Medical Ltd.
Ha'Namal 36
Haifa,  IL 3303203
Applicant Contact Hannoch Marksheid
Correspondent
Hogan Lovells US LLP
1735 Market Street, Suite 2300
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number882.5910
Classification Product Code
GXQ  
Date Received11/14/2022
Decision Date 08/10/2023
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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