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, Urethrographic, Male
510(k) Number K023019
Device Name VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000
Applicant
Vomed Volzer Medizintechnik GmbH & Co.
152b Bridge St.
Hot Springs,  NC  28743
Applicant Contact DAGMAR MASER
Correspondent
Vomed Volzer Medizintechnik GmbH & Co.
152b Bridge St.
Hot Springs,  NC  28743
Correspondent Contact DAGMAR MASER
Regulation Number876.5130
Classification Product Code
FGI  
Date Received09/11/2002
Decision Date 12/10/2002
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
-
-