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 East 69th Street |
Suite 2K |
New York,
NY
10021
|
|
Applicant Contact |
Mark E. Ulrich |
Correspondent |
Ferguson Medical International Device Consultants LLC |
332 Laskin Road, Suite 437 |
Virginia Beach,
VA
23451
|
|
Correspondent Contact |
FRANK FERGUSON |
Regulation Number | 882.5330
|
Classification Product Code |
|
Date Received | 06/23/2015 |
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
|
|
|