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 Case, Contact Lens
510(k) Number K013232
Device Name CYBERCASES BY BAUSCH & LOMB
Applicant
BAUSCH & LOMB, INC.
1400 NORTH GOODMAN ST.
P.O. BOX 30450
ROCHESTER,  NY  14609
Applicant Contact KIM S DEVITTO
Correspondent
BAUSCH & LOMB, INC.
1400 NORTH GOODMAN ST.
P.O. BOX 30450
ROCHESTER,  NY  14609
Correspondent Contact KIM S DEVITTO
Regulation Number886.5928
Classification Product Code
LRX  
Date Received09/27/2001
Decision Date 11/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-