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 Illuminator, Fiberoptic, Surgical Field
510(k) Number K141781
Device Name KOGENT SPETZLER LIGHTED SUCTION TUBES
Applicant
KATALYST SURGICAL, LLC
754 Goddard ave
Chesterfield,  MO  63005
Applicant Contact MERYL KOCH
Correspondent
KATALYST SURGICAL, LLC
754 Goddard ave
Chesterfield,  MO  63005
Correspondent Contact MERYL KOCH
Regulation Number878.4580
Classification Product Code
HBI  
Subsequent Product Code
FST  
Date Received07/02/2014
Decision Date 04/09/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-