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 Catheter, Urological
510(k) Number K854625
Device Name UROTEC CLOSED IRRIGATIION SYRINGE
Applicant
Urotec Systems Corp.
1000 California Ave.
Pittsburgh,  PA  15212
Applicant Contact SUNIL WADHWANI
Correspondent
Urotec Systems Corp.
1000 California Ave.
Pittsburgh,  PA  15212
Correspondent Contact SUNIL WADHWANI
Regulation Number876.5130
Classification Product Code
KOD  
Date Received11/18/1985
Decision Date 03/04/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-