• 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 K925418
Device Name ENERGIZED CONTAINER SYSTEM
Original Applicant
ABBOTT LABORATORIES
one abbott park rd.
abbott park,  IL  60064 -3500
Original Contact frederick gustafson
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
KZD  
Date Received10/27/1992
Decision Date 11/03/1993
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-