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 Set, Lens, Trial, Ophthalmic
510(k) Number K951437
Device Name OTI MODEL TLS-60
Applicant
OTI MEDICAL LLC.
530 BERCUT DR.
SUITER J
SACRAMENTO,  CA  95814
Applicant Contact WILL MARKLE
Correspondent
OTI MEDICAL LLC.
530 BERCUT DR.
SUITER J
SACRAMENTO,  CA  95814
Correspondent Contact WILL MARKLE
Regulation Number886.1405
Classification Product Code
HPC  
Date Received03/27/1995
Decision Date 04/11/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-