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 dialyzer, capillary, hollow fiber
510(k) Number K871471
Device Name CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15
Applicant
TRAVENOL LABORATORIES, S.A.
WILSON RD. AT ROUTE 120
P.O. BOX 490
ROUND LAKE,  IL  60073
Applicant Contact ROBERT L WILKINSON
Correspondent
TRAVENOL LABORATORIES, S.A.
WILSON RD. AT ROUTE 120
P.O. BOX 490
ROUND LAKE,  IL  60073
Correspondent Contact ROBERT L WILKINSON
Regulation Number876.5820
Classification Product Code
FJI  
Date Received04/14/1987
Decision Date 06/12/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-