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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, Alterable
510(k) Number K141911
Device Name OPTIMUS NEURO SYSTEM
Applicant
OSTEONIC CO., LTD.
2651 E CHAPMAN AVE. STE 110
FULLERTON,  CA  92831
Applicant Contact Priscilla Chung
Correspondent
OSTEONIC CO., LTD.
2651 E CHAPMAN AVE. STE 110
FULLERTON,  CA  92831
Correspondent Contact Priscilla Chung
Regulation Number882.5320
Classification Product Code
GWO  
Subsequent Product Codes
GXR   HBW  
Date Received07/15/2014
Decision Date 02/10/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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