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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 K151692
Device Name BioArchitects Patient Specific Cranial/Craniofacial Plate
Applicant
Bioarchitects USA, LLC
219 E. 69th St.
Suite 2k
New York,  NY  10021
Applicant Contact Mark E. Ulrich
Correspondent
Ferguson Medical International Device Consultants, LLC
332 Laskin Rd.
Suite 437
Virginia Beach,  VA  23451
Correspondent Contact FRANK FERGUSON
Regulation Number882.5330
Classification Product Code
GXN  
Date Received06/23/2015
Decision Date 11/20/2015
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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