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 keratoscope, ac-powered
510(k) Number K895475
Device Name CANON AUTO REF-KERATOMETER RK-2
Applicant
CANON U.S.A., INC.
30-2 SHIMOMARUKO
3-CHOME OHTA-KU
TOKYO 146,  JP
Applicant Contact HIROHISA UCHII
Correspondent
CANON U.S.A., INC.
30-2 SHIMOMARUKO
3-CHOME OHTA-KU
TOKYO 146,  JP
Correspondent Contact HIROHISA UCHII
Regulation Number886.1350
Classification Product Code
HLQ  
Date Received09/11/1989
Decision Date 10/31/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-