• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name products, contact lens care, rigid gas permeable
510(k) Number K122273
Device Name MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS
Original Applicant
MENICON CO. LTD.
187 ballardvale street
suite 180
wilmington,  MA  01887
Original Contact ellen m beucler
Regulation Number886.5918
Classification Product Code
MRC  
Date Received07/30/2012
Decision Date 01/02/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-