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 Spectacle, Magnifying
510(k) Number K844038
Device Name VISITEC MAGNIFYING SPECTACLES
Applicant
Visitec Co.
2043 Whitfield Park Dr.
Sarasota,  FL  33580
Applicant Contact EUGENE H BECKSTEIN
Correspondent
Visitec Co.
2043 Whitfield Park Dr.
Sarasota,  FL  33580
Correspondent Contact EUGENE H BECKSTEIN
Regulation Number886.5840
Classification Product Code
HOI  
Date Received10/16/1984
Decision Date 11/29/1984
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
-
-