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 Container, I.V.
510(k) Number K911567
Device Name DUAL COMPARTMENT TPN BAG 3 LITER
Applicant
Stedim, Inc.
2717 # Main St.
Suite 5
Walnut Creek,  CA  94596
Applicant Contact BRYAN KRAUSE
Correspondent
Stedim, Inc.
2717 # Main St.
Suite 5
Walnut Creek,  CA  94596
Correspondent Contact BRYAN KRAUSE
Regulation Number880.5025
Classification Product Code
KPE  
Date Received04/09/1991
Decision Date 08/02/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-