• 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 keratoprosthesis, permanent implant
510(k) Number K121203
Device Name BOSTON KERATOPROSTHESIS OR BOSTON KPRO
Original Applicant
MASSACHUSETTS EYE & EAR INFIRMARY
49 plain street
north attleboro,  MA  02760
Original Contact brian j edwards
Regulation Number886.3400
Classification Product Code
HQM  
Date Received04/20/2012
Decision Date 05/10/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-