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, Suprapubic (And Accessories)
510(k) Number K014002
Device Name ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890
Applicant
Fortune Medical Instrument Corp.
12-9, Lin 5, Mao-Chang Village
San-Chih Hsiang
Taipei Hsien,  TW 252
Applicant Contact ABE WANG
Correspondent
Fortune Medical Instrument Corp.
12-9, Lin 5, Mao-Chang Village
San-Chih Hsiang
Taipei Hsien,  TW 252
Correspondent Contact ABE WANG
Regulation Number876.5090
Classification Product Code
KOB  
Date Received12/04/2001
Decision Date 03/04/2002
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
-
-