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 Keratoprosthesis, Temporary Implant, Surgical Use
510(k) Number K842856
Device Name LANDERS-FOULKS TEMP. KERATOPROSTHESIS
Applicant
Ocular Instruments, Inc.
12100 Northup Way
Suite D
Bellevue,  WA  98005
Applicant Contact JAMES P ERICKSON
Correspondent
Ocular Instruments, Inc.
12100 Northup Way
Suite D
Bellevue,  WA  98005
Correspondent Contact JAMES P ERICKSON
Regulation Number886.3400
Classification Product Code
MLP  
Date Received07/20/1984
Decision Date 12/18/1984
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
-
-