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 frame, trial, ophthalmic
510(k) Number K821084
Device Name UNIVERSAL TRIAL FRAMEE
Applicant
MEDICAL EQUIPMENT DESIGNS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MEDICAL EQUIPMENT DESIGNS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number886.1415
Classification Product Code
HPA  
Date Received04/19/1982
Decision Date 06/14/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-