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 pump, infusion
510(k) Number K002126
Device Name ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP
Applicant
ABBOTT LABORATORIES
DEPT. 389, AP30
200 ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3537
Applicant Contact JILL SACKETT
Correspondent
ABBOTT LABORATORIES
DEPT. 389, AP30
200 ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3537
Correspondent Contact JILL SACKETT
Regulation Number880.5725
Classification Product Code
FRN  
Date Received07/14/2000
Decision Date 07/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
-
-