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

TPLC - Total Product Life Cycle

  • 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 graft insertion instrument for endothelial keratoplasty
Regulation Description Intraocular lens guide.
Definition A graft insertion device for endothelial keratoplasty is a device intended to be inserted into the eye during surgery to direct the insertion of a corneal graft and be removed after insertion is completed.
Product CodeOTZ
Regulation Number 886.4300
Device Class 1


Premarket Reviews
ManufacturerDecision
FISCHER SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

-
-