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 K000485
Device Name HYDRO2, HS-75
Applicant
Innovision, Inc.
3125 S. 61st Ave.
Omaha,  NE  68106 -3675
Applicant Contact DON M WOODFORD
Correspondent
Innovision, Inc.
3125 S. 61st Ave.
Omaha,  NE  68106 -3675
Correspondent Contact DON M WOODFORD
Regulation Number886.5916
Classification Product Code
HQD  
Date Received02/14/2000
Decision Date 05/12/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-