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 Case, Contact Lens
510(k) Number K874657
Device Name RIGID-LENS CASE
Applicant
Sola Ophthalmics
1100 E. Bell Rd.
P.O. Box 39600
Phoenix,  AZ  85022
Applicant Contact KRISTINE A FOSS
Correspondent
Sola Ophthalmics
1100 E. Bell Rd.
P.O. Box 39600
Phoenix,  AZ  85022
Correspondent Contact KRISTINE A FOSS
Regulation Number886.5928
Classification Product Code
LRX  
Date Received11/19/1987
Decision Date 12/08/1987
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
-
-