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 Lenses, Soft Contact, Daily Wear
510(k) Number K983637
Device Name ACTIFRESH 400 LENS
Applicant
HYDRON LTD.
HAWLEY LANE
FARNBOROUGH, HANTS,  GB GU14 8EQ
Applicant Contact JULIAN B HOLLOWAY
Correspondent
HYDRON LTD.
HAWLEY LANE
FARNBOROUGH, HANTS,  GB GU14 8EQ
Correspondent Contact JULIAN B HOLLOWAY
Regulation Number886.5925
Classification Product Code
LPL  
Date Received10/16/1998
Decision Date 12/10/1999
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
-
-