Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Orthosis, Cranial
510(k) Number K203134
Device Name Hanger Cranial Band 3D
Applicant
Symbion Logistics, LLC
1119 W Geneva Dr.
Tempe,  AZ  85281
Applicant Contact Roselle Abad
Correspondent
Symbion Logistics, LLC
1119 W Geneva Dr.
Tempe,  AZ  85281
Correspondent Contact Roselle Abad
Regulation Number882.5970
Classification Product Code
MVA  
Subsequent Product Code
OAN  
Date Received10/19/2020
Decision Date 07/01/2022
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
-
-