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 K924033
Device Name ALTEX MODEL UST-3000E
Applicant
Optro-Mechanics (Usa) Corp.
One Blue Hill Plz.
Pearl River,  NY  10965
Applicant Contact SAL A CORTORILLO
Correspondent
Optro-Mechanics (Usa) Corp.
One Blue Hill Plz.
Pearl River,  NY  10965
Correspondent Contact SAL A CORTORILLO
Regulation Number886.4670
Classification Product Code
HQC  
Date Received08/11/1992
Decision Date 11/05/1992
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
-
-