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 set, administration, intravascular
510(k) Number K961225
Device Name CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET
Applicant
BAXTER HEALTHCARE CORP.
ROUTE 120 AND WILSON RD.
ROUND LAKE,  IL  60073
Applicant Contact MARY ELLEN SNYDER
Correspondent
BAXTER HEALTHCARE CORP.
ROUTE 120 AND WILSON RD.
ROUND LAKE,  IL  60073
Correspondent Contact MARY ELLEN SNYDER
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/29/1996
Decision Date 06/21/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-