• 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 | Inspections
 


New Search Back To Search Results
Device Classification Name set, administration, intravascular
510(k) Number K981318
FOIA Releasable 510(k) K981318
Device Name DUAL LUER LOCK CAP
Applicant
BAXTER HEALTHCARE CORP.
rt. 120 & wilson rd.
round lake,  IL  60073
Applicant Contact mary ellen snyder
Correspondent
BAXTER HEALTHCARE CORP.
rt. 120 & wilson rd.
round lake,  IL  60073
Correspodent Contact mary ellen snyder
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/10/1998
Decision Date 04/22/1998
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
-
-