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, Spectacle
510(k) Number K940504
Device Name SPECTACLE FRAMES
Applicant
Tecnol-Tecnica Nacional DE Oculos Ltda
J. Santa Candida
13085 Campinas - Sp
Brazil,  BR
Applicant Contact JOSE MAURO T. MOLINA
Correspondent
Tecnol-Tecnica Nacional DE Oculos Ltda
J. Santa Candida
13085 Campinas - Sp
Brazil,  BR
Correspondent Contact JOSE MAURO T. MOLINA
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received02/03/1994
Decision Date 05/17/1994
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
-
-