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 System, Irrigation, Urological
510(k) Number K040094
Device Name PIGGYBACK IRRIGATING SYSTEM
Applicant
Kosin Technologies, LLC
3305 Greyfox Dr.
Valparaiso,  IN  46383
Applicant Contact AVTAR S DHINDSA
Correspondent
Kosin Technologies, LLC
3305 Greyfox Dr.
Valparaiso,  IN  46383
Correspondent Contact AVTAR S DHINDSA
Regulation Number876.5130
Classification Product Code
LJH  
Date Received01/16/2004
Decision Date 04/15/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-