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 shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)
510(k) Number K894720
Device Name UNIVERSAL EYESHIELD
Applicant
TRIDENT MEDICAL PRODUCTS, INC.
308 S. HENDERSON
FORT WORTH,  TX  76104
Applicant Contact DAN E BRUHL
Correspondent
TRIDENT MEDICAL PRODUCTS, INC.
308 S. HENDERSON
FORT WORTH,  TX  76104
Correspondent Contact DAN E BRUHL
Regulation Number886.4750
Classification Product Code
HOY  
Date Received07/25/1989
Decision Date 09/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-