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, Retention Type, Balloon
510(k) Number K945806
Device Name SILICATH ALL SILICONE FOLEY CATHETER
Applicant
Unomedical Sdn Bhd
Bakar Arang Industrial Estate
P.O. Box 18
Sungai Petani, Kedah,  MY 08007
Applicant Contact LIM K KANG
Correspondent
Unomedical Sdn Bhd
Bakar Arang Industrial Estate
P.O. Box 18
Sungai Petani, Kedah,  MY 08007
Correspondent Contact LIM K KANG
Regulation Number876.5130
Classification Product Code
EZL  
Date Received11/28/1994
Decision Date 03/21/1995
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
-
-