• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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 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
-
-