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

Device Classification Under Section 513(f)(2)(De Novo)

  • 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 scalp cooling system
De Novo Number DEN150010
Device Name Dignitana AB DigniCap System
Requester
dignitana ab
traktorgranden 3
lund,  SE se-226 60
Contact jan richardsson
Regulation Number878.4360
Classification Product Code
PMC  
Date Received03/06/2015
Decision Date 12/08/2015
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
-
-