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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 K240567
Device Name CustomizedBone Service
Applicant
Fin-ceramica faenza s.p.a.
Via Ravegnana 186
Faenza,  IT 48018
Applicant Contact Marina Monticelli
Correspondent
Fortrea
5353 Wayzata Boulevard, Suite 505
Minneapolis,  MN  55416 -1334
Correspondent Contact Stephanie Perryman
Regulation Number882.5330
Classification Product Code
GXN  
Subsequent Product Code
PJN  
Date Received02/29/2024
Decision Date 03/28/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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