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 K083723
Device Name A6 LUER ACCESS DEVICE
Applicant
B. BRAUN MEDICAL, INC.
901 MARCON BLVD.
ALLENTOWN,  PA  18109 -9341
Applicant Contact BONNIE J KINCAID, RAC
Correspondent
B. BRAUN MEDICAL, INC.
901 MARCON BLVD.
ALLENTOWN,  PA  18109 -9341
Correspondent Contact BONNIE J KINCAID, RAC
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/15/2008
Decision Date 06/05/2009
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
-
-