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, contact, polymethylmethacrylate, diagnostic
510(k) Number K862868
Device Name ABRAHAM YAG LASER LENS
Applicant
OCULAR INSTRUMENTS, INC.
12100 NORTHUP WAY
SUITE D
BELLEVUE,  WA  98005
Applicant Contact TAMSIN J ERICKSON
Correspondent
OCULAR INSTRUMENTS, INC.
12100 NORTHUP WAY
SUITE D
BELLEVUE,  WA  98005
Correspondent Contact TAMSIN J ERICKSON
Regulation Number886.1385
Classification Product Code
HJK  
Date Received07/29/1986
Decision Date 08/21/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-