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 Refractometer, Ophthalmic
510(k) Number K904828
Device Name OPTEC 2300 AFVT, ARMED FORCES VISION TESTER
Applicant
Stereo Optical Co., Inc.
3539 N. Kenton
Chicago,  IL  60641
Applicant Contact JOSEPH ANDERA
Correspondent
Stereo Optical Co., Inc.
3539 N. Kenton
Chicago,  IL  60641
Correspondent Contact JOSEPH ANDERA
Regulation Number886.1760
Classification Product Code
HKO  
Date Received10/24/1990
Decision Date 01/18/1991
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
-
-