• 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 | 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 lens, contact (other material) - daily
510(k) Number K013646
Device Name ROSE K POST GRAFT LENS
Applicant
ROSE K INTERNATIONAL LTD.
60 ST. ANDREWS TCE
HAMILTON,  NZ
Applicant Contact IAN JENNINGS
Correspondent
ROSE K INTERNATIONAL LTD.
60 ST. ANDREWS TCE
HAMILTON,  NZ
Correspondent Contact IAN JENNINGS
Regulation Number886.5916
Classification Product Code
HQD  
Date Received11/05/2001
Decision Date 05/30/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-