Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 K062548
Device Name MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES
Applicant
CONTAMAC LTD.
2214 SANFORD DRIVE
UNIT B7
GRAND JUNCTION,  CO  81505
Applicant Contact MARTIN DALSING
Correspondent
CONTAMAC LTD.
2214 SANFORD DRIVE
UNIT B7
GRAND JUNCTION,  CO  81505
Correspondent Contact MARTIN DALSING
Regulation Number886.5916
Classification Product Code
HQD  
Date Received08/30/2006
Decision Date 11/01/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-