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

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Device endoilluminator, reprocessed
Regulation Description Endoscope and accessories.
Definition Used intraocularly to provide light into the posterior of the eye during retinal surgery.Same as product code mpa, except this one is reprocessed.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Ophthalmic
Product CodeNKZ
Premarket Review Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Intraocular and Corneal Implants Devices Branch (ICIB)
Submission Type 510(k)
Regulation Number 876.1500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
-
-