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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 K210616
Device Name Longeviti PMMA Static 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 Received03/01/2021
Decision Date 03/31/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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