• 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 | 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 K954283
Device Name ENERGIZED CONTAINER SYSTEM (MODIFICATION)
Original Applicant
ABBOTT LABORATORIES
dept. 389, ap30
200 abbott park rd.
abbott park,  IL  60064 -3537
Original Contact david t guzek
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/05/1995
Decision Date 05/29/1996
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-