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 Engine, Trephine, Accessories, Ac-Powered
510(k) Number K843957
Device Name ULTRATHIN/SP LENS
Applicant
Optical Systems Intl., Inc.
1652 W. 32nd. Pl.
Hialeah,  FL  33012
Applicant Contact EDWARD DERAJAS
Correspondent
Optical Systems Intl., Inc.
1652 W. 32nd. Pl.
Hialeah,  FL  33012
Correspondent Contact EDWARD DERAJAS
Regulation Number886.4070
Classification Product Code
HRG  
Date Received10/10/1984
Decision Date 07/31/1985
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
-
-