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 Needle, Fistula
510(k) Number K854773
Device Name SUPERCATH A.V. FISTULA
Applicant
Togo Medikit Co., Ltd.
Shoei-Survgadai Bldg
1-2 Kanda-Surugadai 3 Chome
Chiyoda-Ku Tokyo101 Japan,  JP
Applicant Contact HIROAKI NAKAJIMA
Correspondent
Togo Medikit Co., Ltd.
Shoei-Survgadai Bldg
1-2 Kanda-Surugadai 3 Chome
Chiyoda-Ku Tokyo101 Japan,  JP
Correspondent Contact HIROAKI NAKAJIMA
Regulation Number876.5540
Classification Product Code
FIE  
Date Received11/29/1985
Decision Date 04/08/1986
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
-
-