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 K192418
Device Name Phacoemulsification Needle (Tip) and Irrigation Sleeve
Applicant
Raico, LLC
26 Plz. Dr.
Westmont,  IL  60559
Applicant Contact Ravi Nallakrishnan
Correspondent
Raico, LLC
26 Plz. Dr.
Westmont,  IL  60559
Correspondent Contact Ravi Nallakrishnan
Regulation Number886.4670
Classification Product Code
HQC  
Date Received09/04/2019
Decision Date 05/27/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-