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 Table, Instrument, Powered, Ophthalmic
510(k) Number K912134
Device Name TBD, LENS MEASURING DEVICE
Applicant
Alcon Laboratories
6201 S. Fwy. R7-14
Fort Worth,  TX  76134
Applicant Contact DAVID KRAPF
Correspondent
Alcon Laboratories
6201 S. Fwy. R7-14
Fort Worth,  TX  76134
Correspondent Contact DAVID KRAPF
Regulation Number886.4855
Classification Product Code
HRJ  
Date Received05/14/1991
Decision Date 07/25/1991
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
-
-