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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
Ceremed , Inc.
3643 Lenawee Ave
Los Angeles,  CA  90016
Applicant Contact Chelsea Mitchell
Ceremed , Inc.
3643 Lenawee Ave
Los Angeles,  CA  90016
Correspondent Contact Chelsea Mitchell
Regulation Number882.5320
Classification Product Code
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