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 ophthalmoscope, ac-powered
510(k) Number K843812
Device Name WOODLYN CLASSIC CATARACT ACUITY TEST
Applicant
WOODLYN, INC.
2920 MALMO DR.
ARLINGTON HEIGHTS,  IL  60005 -4726
Applicant Contact RONALD NIELSEN
Correspondent
WOODLYN, INC.
2920 MALMO DR.
ARLINGTON HEIGHTS,  IL  60005 -4726
Correspondent Contact RONALD NIELSEN
Regulation Number886.1570
Classification Product Code
HLI  
Date Received09/28/1984
Decision Date 12/11/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-