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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Cranioplasty, Preformed, Non-Alterable
510(k) Number K231920
Device Name Longeviti ClearFit OTS Cranial Implant
Applicant
Longeviti Neuro Solutions, LLC
303 International Circle, Suite 190
Hunt Valley,  MD  21030
Applicant Contact Jesse Christopher
Correspondent
Longeviti Neuro Solutions
303 International Circle, Suite 190
Hunt Valley,  MD  21030
Correspondent Contact Brianna Myers
Regulation Number882.5330
Classification Product Code
GXN  
Date Received06/29/2023
Decision Date 11/09/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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