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 unit, phacofragmentation
510(k) Number K954340
Device Name STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE
Applicant
STORZ
3365 TREE COURT INDUSTRIAL
BOULEVARD
ST. LOUIS,  MO  63122
Applicant Contact AUDREY SWEARINGEN
Correspondent
STORZ
3365 TREE COURT INDUSTRIAL
BOULEVARD
ST. LOUIS,  MO  63122
Correspondent Contact AUDREY SWEARINGEN
Regulation Number886.4670
Classification Product Code
HQC  
Date Received09/18/1995
Decision Date 12/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-