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 Sunglasses (Non-Prescription Including Photosensitive)
510(k) Number K890081
Device Name CALIUS-ISABEL CANOVAS SUNGLASSES
Applicant
Roseburg SA
Suite 120 Canal Sq.
1054 31st St. NW
Washington,  DC  20007
Applicant Contact DARIENNE MOYER
Correspondent
Roseburg SA
Suite 120 Canal Sq.
1054 31st St. NW
Washington,  DC  20007
Correspondent Contact DARIENNE MOYER
Regulation Number886.5850
Classification Product Code
HQY  
Date Received01/10/1989
Decision Date 03/09/1989
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
-
-