• 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 corneal storage media with preservatives including anti-fungal
De Novo Number DEN200063
Device Name Kerasave
Requester
al.chi.mi.a. s.r.l
viale austria, 14
ponte san nicolo,  IT 35020
Contact mauro beccaro
Regulation Number886.4320
Classification Product Code
QCW  
Date Received10/01/2020
Decision Date 05/02/2022
Decision granted (DENG)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
-
-