• 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 unit, phacofragmentation
510(k) Number K041998
Device Name PHACO CHOP NEEDLES
Applicant
BAUSCH & LOMB, INC.
3365 TREE CT. INDUSTRIAL BLVD.
ST. LOUIS,  MO  63122 -6694
Applicant Contact DENNIS POZZO
Correspondent
BAUSCH & LOMB, INC.
3365 TREE CT. INDUSTRIAL BLVD.
ST. LOUIS,  MO  63122 -6694
Correspondent Contact DENNIS POZZO
Regulation Number886.4670
Classification Product Code
HQC  
Date Received07/26/2004
Decision Date 08/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-