• 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, retention type, balloon
510(k) Number K013174
Device Name PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL,
Applicant
PORGES S.A.
USINE DU PONTET BP 89
SARLAT,  FR 24203
Applicant Contact BERNARD ISMAEL
Correspondent
PORGES S.A.
USINE DU PONTET BP 89
SARLAT,  FR 24203
Correspondent Contact BERNARD ISMAEL
Regulation Number876.5130
Classification Product Code
EZL  
Date Received09/24/2001
Decision Date 01/04/2002
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
-
-