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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 K161446
Device Name Biopor Porous Polyethylene Implants
Applicant
Ceremed , Inc.
3643 Lenawee Ave
Los Angeles,  CA  90016
Applicant Contact Chelsea Mitchell
Correspondent
Ceremed , Inc.
3643 Lenawee Ave
Los Angeles,  CA  90016
Correspondent Contact Chelsea Mitchell
Regulation Number882.5320
Classification Product Code
GWO  
Date Received05/25/2016
Decision Date 09/27/2016
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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