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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 K202901
Device Name Longeviti ClearFit Cranial Implant
Applicant
Longeviti Neuro Solutions, LLC
303 International Circle, Suite 190
Hunt Valley,  MD  21030
Applicant Contact Heather Hourihan
Correspondent
Longeviti Neuro Solutions, LLC
303 International Circle, Suite 190
Hunt Valley,  MD  21030
Correspondent Contact Heather Hourihan
Regulation Number882.5330
Classification Product Code
GXN  
Subsequent Product Code
PJN  
Date Received09/29/2020
Decision Date 10/30/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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