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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
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