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 K933809
Device Name OPTO LINE SRL
Applicant
Optoline S.R.L.
Via Della Centa
34 - Z.I. 31040
Segusino (Tv),  IT
Applicant Contact ADAMI GILBERTO
Correspondent
Optoline S.R.L.
Via Della Centa
34 - Z.I. 31040
Segusino (Tv),  IT
Correspondent Contact ADAMI GILBERTO
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received08/04/1993
Decision Date 10/18/1993
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
-
-