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 Products, Contact Lens Care, Rigid Gas Permeable
510(k) Number K182984
Device Name MaxiTears Contacts PF
Applicant
Omnivision AG
Zentralstr. 100
Neuhausen am Rheinfall,  CH CH-8212
Applicant Contact Joachim Kolter
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Road, Building 1, Suite 300
Austin,  TX  78746
Correspondent Contact Oliver Eikenberg
Regulation Number886.5918
Classification Product Code
MRC  
Subsequent Product Code
LPN  
Date Received10/29/2018
Decision Date 07/24/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-