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 K980808
Device Name ENDO FMS UROLOGY
Applicant
Future Medical Systems, Inc.
504 Mccormick Dr.
Suite T
Glen Burnie,  MD  21061
Applicant Contact PATRICK JANIN
Correspondent
Future Medical Systems, Inc.
504 Mccormick Dr.
Suite T
Glen Burnie,  MD  21061
Correspondent Contact PATRICK JANIN
Regulation Number876.5130
Classification Product Code
LJH  
Subsequent Product Code
FDC  
Date Received03/03/1998
Decision Date 05/08/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-