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 lens, spectacle, non-custom (prescription)
510(k) Number K873245
Device Name AR DIACOAT SINGLE VISION LENSES
Applicant
SEIKO OPTICAL PRODUCTS OF AMERICA, INC.
575 CORPORATE DR.
MAHWAH,  NJ  07430
Applicant Contact ROBERT L CURLEY
Correspondent
SEIKO OPTICAL PRODUCTS OF AMERICA, INC.
575 CORPORATE DR.
MAHWAH,  NJ  07430
Correspondent Contact ROBERT L CURLEY
Regulation Number886.5844
Classification Product Code
HQG  
Date Received08/17/1987
Decision Date 10/05/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-