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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 K193547
FOIA Releasable 510(k) K193547
Device Name CustomizedBone Service
Applicant
Fin-Ceramica Faenza Spa
Via Ravegnana 186
Faenza,  IT 48018
Applicant Contact Marina Monticelli
Correspondent
Regulatory and Clinical Research Institute, Inc.
5353 Wayzata Blvd, Suite 505
Minneapolis,  MN  55416
Correspondent Contact Mary Beth Henderson
Regulation Number882.5330
Classification Product Code
GXN  
Subsequent Product Code
PJN  
Date Received12/20/2019
Decision Date 01/17/2020
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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