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 K993489
Device Name CRYSTAL CUSTOM TINTED SOFT CONTACT LENS
Applicant
Crystal Reflections, Int., Inc.
1325 Progress Dr.
Front Royal,  VA  22630
Applicant Contact JACK CARTER
Correspondent
Crystal Reflections, Int., Inc.
1325 Progress Dr.
Front Royal,  VA  22630
Correspondent Contact JACK CARTER
Regulation Number886.5925
Classification Product Code
LPL  
Date Received10/15/1999
Decision Date 04/14/2000
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
-
-