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 Accelerator, Linear, Medical
510(k) Number K131795
Device Name NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS
Applicant
Orfit Industries NV
Vosveld 9a
Wijnegem,  BE 2110
Applicant Contact EDDY MARIVOET
Correspondent
Orfit Industries NV
Vosveld 9a
Wijnegem,  BE 2110
Correspondent Contact EDDY MARIVOET
Regulation Number892.5050
Classification Product Code
IYE  
Date Received06/18/2013
Decision Date 09/26/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-